Kamalesh Kumar Sankhala, M.D. Chief, Translational and Clinical Research

Diplomate, American Board of Medical Oncology

2811 Wilshire Blvd Suite # 414

Santa Monica, CA 90210

Phone: 310-552-9999

Fax: 310-201-6685

Email: sankhalak@aol.com

Current Position: 2014 – Current

• Chief, Translational and Clinical Research, Sarcoma Oncology Research Center, LLC / Cancer Center

of Southern California Santa Monica CA

• Medical Oncologist, Sarcoma Oncology Research Center, LLC /Cancer Center of Southern California

Previous Positions: 2012 – 2013

• Assistant Professor, Department of Medicine

• Team Leader, Sarcoma Medical Oncology

• Clinical Investigator, Institute for Drug Development, CTRC

Division of Hematology-Oncology

University of Texas Health Science Center, San Antonio

Education: Earned ABIM accreditation for board certification in Internal Medicine and Medical Oncology while working as

Clinical Investigator at IDD from 01/2008 to 12/2011 by special approval by ABIM.

• Fellowship in Medical Oncology

Division of Hematology-Oncology

University of Texas Health Science Center at San Antonio TX

January 2008 to December 2009

• Advanced Drug Development Fellowship

Institute for Drug Development, Cancer Therapy and Research Center

University of Texas Health Science Centre at San Antonio TX

San Antonio, TX 78229

September 2006 to December 2007

• Fellowship (senior residency) in Hematology-Oncology

Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India

March 2001 to October 2003

• Residency in Internal Medicine (three years program)

University of Rajasthan, Ravindra Nath Tagore Medical College, India

October 1997 to October 2000

• Residency in Internal Medicine (Two years program approved by ABIM)

University of Texas Health Science Center at San Antonio TX

January 2010 to December 2011

• M.B.B.S (Medical school & one year compulsory rotating internship)

University of Rajasthan, Sampurna Nand Medical College, India

March, 1997

Awards/Accomplishments

• ‘The American Society of Clinical Oncology Foundation Merit Award 2005’ for the young researcher

for presentation data on role of PET scan to evaluate tumor response in patients with Sarcoma

• AACR-NCI Workshop Scholarship “Molecular Biology in Clinical Oncology”, Aspen Colorado 2007.

ECFMG Certification:

• Number: 0-667-136-6

Date: March 31, 2006

Board Certification (ABIM # 325547)

• ABIM Internal Medicine -Recertification due in 2022

• ABIM Medical Oncology - Recertification due in 2024

US Licensing Examinations (USMLE)

• USMLE Step 1 (Score: 92 & 226)

• USMLE Step 2 CK (Clinical Knowledge) (Score: 98 & 243)

• USMLE Step 2 CS (Clinical Skills) (Passed)

• USMLE Step 3 (Passed)

State Medical Board Licenses:

• Texas Medical Board (License # N9776)

• California Medical Board (License # A119127)

Previous Training:

• Clinical Research Fellowship (Oncology)

• November 2003 to August 2006

• Sarcoma Oncology Center, Los Angeles, California

Advanced Drug Development Fellowship

• Institute for Drug Development, Cancer Therapy and Research Center

University of Texas Health Science Centre at San Antonio TX

San Antonio, TX 78229

September 2006 to December 2007

Membership in Honorary/Professional Societies

• ASCO (American Society of Clinical Oncology)

• AACR (American Association of Cancer Research)

• CTOS (Connective Tissue Oncology Society)

• TMA (Texas Medical Association)

• TSMO (Texas Society of Medical Oncology)

Reviewer as peer for Journals: 1. British Journal of Cancer

Manuscript ID: CL/2013/7183

2. Cancer Chemotherapy & Pharmacology

Manuscript ID: CCP-10-0444

3. Journal of Medical Case Report

Manuscript number: 1154689410317786

4. Onkologie

Manuscript number: 200910014

5. Bone Marrow Transplantation

Manuscript number: BMT-2011-694

Member of editorial Board for: 1. Journal of Cancer Science & Therapy

2. Chemotherapy: open access

Honorary:

• Member Protocol Review Committee 2012 - 2013, University of Texas

Editorial invitations for:

• Managing editorialship for ‘Frontiers in Bioscience’

• Guest editor for ‘Recent Patents on Drug Delivery & Formulation’

• Guest editor for ‘Recent Patent on Anti-Cancer Drug Discovery’

• Guest editor for ‘Current Molecular Pharmacology’

• Guest editor for ‘Cardiovascular & Hematological Disorder – Drug Targets’

• Guest editor for ‘Current Drug Safety’

Publications:

Peer reviewed publications: 1. First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue

Sarcoma A Phase 2b Randomized Clinical Trial . ) JAMA Oncology Published online September 17,

2015, Sant P. Chawla, MD; Zsuzsanna Papai, MD; Guzel Mukhametshina,MD; Kamalesh Sankhala, MD;

Leonid Vasylyev, MD; Alexander Fedenko, MD; Kenneth Khamly, MD; Kristen Ganjoo, MD; Rajnish

Nagarkar, MD; Scott Wieland, PhD; Daniel J. Levitt, MD

2. Randomized phase 2b trial comparing first-line treatment with aldoxorubicin versus doxorubicin in

patients with advanced soft tissue sarcomas. J Clin Oncol 32:5s, 2014. Authors: Sant P. Chawla,

Zsuzsanna Papai, Kamalesh Sankhala, Leonid Vasylyev, Guzel Mukhametsina, Mamed Aliev, Kenneth

Khamly, Scott Wieland, Daniel J. Levitt.

3. Low-dose gemcitabine doxorubicin and docetaxel combination in patients with

advanced/unresectable/metastatic sarcoma who failed prior chemotherapy: Updated analysis. J Clin

Oncol 32:5s, 2014. Authors: Vivek Narasimhan, James Hu, Kamalesh Kumar Sankhala, Doris V. Quon,

Lawrence Menendez, Lita Fernandez, Victoria S Chua, Sant P. Chawla; Sarcoma Oncology Center,

Santa Monica, CA; USC Norris Comprehensive Cancer Center, Los Angeles, CA.

4. 14-day continuous infusion ifosfamide in advanced refractory sarcomas. JClin Oncol 32:5s, 2014.

Authors: Arun S. Singh, Kamalesh Kumar Sankhala, Arnob Mukherjee, Vivek Narasimha, Bartosz

Chmielowski, Doris V. Quon, Vicky Chua, Sant P. Chawla.

5. A phase 1B/2 study of aldoxorubicin in patients with soft tissue sarcoma. Chawla SP1, Chua VS,

Hendifar AF, Quon DV, Soman N, Sankhala KK, Wieland DS, Levitt DJ. Cancer. 2015 Feb 15;121(4):570-

doi: 10.1002/cncr.29081. Epub 2014 Oct 13

6. Phase I study of intravenously administered ATI-1123, a liposomal docetaxel formulation in patients

with advanced solid tumors. Mahalingam D1, Nemunaitis JJ, Malik L, Sarantopoulos J, Weitman S,

Sankhala K, Hart J, Kousba A, Gallegos NS, Anderson G, Charles J, Rogers JM, Senzer NN, Mita AC.

Cancer Chemother Pharmacol. 2014 Dec;74(6):1241-50. doi: 10.1007/s00280-014-2602-x. Epub 2014

Oct 11

7. Phase II study evaluating the efficacy, safety, and pharmacodynamics correlative study of dual

antiangiogenic inhibition using bevacizumab in combination with sorafenib in patients with advanced

malignant melanoma. Mahalingam D, Malik L, Beeram M, Rodon J, Sankhala K, Mita A, Benjamin D,

Ketchum N, Michalek J, Tolcher A, Wright J, Sarantopoulos J. Cancer Chemother Pharmacol. 2014

Jul;74(1):77-84. doi: 10.1007/s00280-014-2479-8. Epub 2014 May 10.

8. Randomized phase II trial of the cyclin-dependent kinase inhibitor dinaciclib (MK-7965) versus

capecitabine in patients with advanced breast cancer. Mita MM, Joy AA, Mita A, Sankhala K, Jou YM,

Zhang D, Statkevich P, Zhu Y, Yao SL, Small K, Bannerji R, Shapiro CL. Clin Breast Cancer. 2014

Jun;14(3):169-76. doi: 10.1016/j.clbc.2013.10.016. Epub 2013 Oct 26.

9. Partial response of a rare malignant metastatic diffuse tenosynovial giant cell tumor with benign

histologic features, treated with SCH 717- 454, an insulin growth factor receptor inhibitor, in

combination with everolimus, an MTOR inhibitor. Sikaria S1, Heim-Hall J, Diaz EH, Williams R, Sankhala

K, Laabs B, Mita M. Target Oncol. 2014 Mar;9(1):73-9. doi: 10.1007/s11523-013-0267-8. Epub 2013 Feb 21.

10. A phase l study of three different dosing schedules of the oral aurora kinase inhibitor MSC1992371A

in patients with solid tumors; M. Mita, M. Gordon, N. Rejeb, A. Gianella-Borradori, V. Jego, A. Mita, J.

Sarantopoulos, K. Sankhala, D. Mendelson; Targeted Oncology; July 2013. Target Oncol. 2014

Sep;9(3):215-24. doi: 10.1007/s11523-013-0288-3. Epub 2013 Jul 6.

11. Safety, Pharmacokinetics and Activity of GRN1005, a Novel Conjugate of Angiopep-2, a Peptide

Facilitating Brain Penetration, and Paclitaxel, in Patients with Advanced Solid Tumors; Kurzrock R,

Gabrail NY, Chandhasin C, Moulder SL, Smith C, Brenner AJ, Sankhala K, Mita AC, Elian K, Bouchard

DC, Sarantopoulos; J. Mol Cancer Ther. 2011 Dec 27.

12. Phase II Study of the Mammalian Target of Rapamycin Inhibitor Ridaforolimus in Patients with

Advanced Bone and Soft Tissue Sarcomas; Chawla SP, Staddon AP, Baker LH, Schuetze SM, Tolcher

AW, D'Amato GZ, Blay JY, Mita MM, Sankhala KK, Berk L, Rivera VM, Clackson T, Loewy JW, Haluska

FG, Demetri GD; J Clin Oncol. 2012 Jan 1;30(1):78-84. Epub 2011 Nov 7.

13. Heat Shock Proteins: A Potential Anticancer Target. Sankhala KK, Mita MM, Mita AC, Takimoto CH;

Curr Drug Targets. 2011 Jul 21.

14. The emerging role of mammalian target of rapamycin inhibitors in the treatment of sarcomas.

Vemulapalli S, Mita A, Alvarado Y, Sankhala K, Mita M; Target Oncol. 2011 Mar;6(1):29-39. Epub 2011

Apr 28. Review.

15. Phase I/II multicenter study to assess the safety, tolerability, pharmacokinetics and

pharmacodynamics of AZD4877 in patients with refractory acute myeloid leukemia; H Kantarjian, S

Padmanabhan, W Stock, MS Tallman, GA Curt, K Wu, J Li, A Osmukhina, D Huszar, G Borthukar, S

Faderl, G Garcia-Manero, T Kadia, K Sankhala, T Odenike, JK Altman, M Minden; Investigational New

Drugs today.

16. Phase I and Pharmacokinetic Study of CT-322 (BMS-844203), a Targeted Adnectin Inhibitor of

VEGFR-2 Based on a Domain of Human Fibronectin; Anthony W. Tolcher, Christopher J. Sweeney,

Kyri Papdopoulos, Amita Patnaik, Elena G. Chiorean, Alain C. Mita, Kamalesh Sankhala, Eric Furfine,

Jochem Gokemeijer, Lisa Iacono, Cheryl Eaton, Bruce A. Silver, Monica Mita; Clinical Cancer Research.

2011 Jan 15; 17 (2): 363-71. Epub 2011 Jan 11.

17. Phase 1 study of AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with

chemotherapy in adults with advanced solid tumors; Mita AC, Takimoto CH, Mita M, Tolcher A,

Sankhala K, Sarantopoulos J, Valdivieso M, Wood L, Rasmussen E, Sun YN, Zhong ZD, Bass MB, Le N,

LoRusso P.; Clinical Cancer Research. 2010 Jun 1;16(11):3044-56. Epub 2010 May 25

18. Prevention of chemotherapy induced nausea and vomiting: a focus on aprepitant; Sankhala KK,

Pandya DM, Sarantopoulos J, Soefje SA, Giles FJ, Chawla SP; Expert Opinion in Drug Metab Toxicol.

2009 Dec;5 (12):1607-14.

19. Targeting sarcomas: novel biological agents and future perspectives; Mahalingam D, Mita A, Sankhala

K, Swords R, Kelly K, Giles F, Mita MM; Current Drug Targets, 2009 Oct 10(10): 937-49

20. Desmoplastic Small Round Cell Tumor (DSRCT): Current treatment approach and role of targeted

therapy; Kamalesh K. Sankhala, Sant P. Chawla; Clinical advances in Hematology and Oncology; July

2009 Volume 7, Issue 7.

21. The potential of Mammalian target of rapamycin (mTOR) inhibitors as therapeutic agents in

hematological malignancies” Kamalesh Sankhala, Francis J. Giles; Expert Review of Hematology;

August 2009, Vol. 2, No. 4, Pages 399-414.

22. The emerging safety profile of mTOR inhibitors. A novel class of anticancer agents; Sankhala K, Mita

A, Kelly K, Mahalingam D, Giles F, Mita M; Targeted Oncol. 2009 Apr; 4(2):135-42. Epub 2009 Apr 21.

23. Targeting the mTOR pathway using Deforolimus in cancer therapy; Devalingam Mahalingam,

Kamalesh Sankhala, Francis Giles and Monica Mita; Future Oncol. 2009 Apr;5(3):291-303

24. Acute Lymphoblastic Leukemia presenting with avascular necrosis of the elbow. Kelly K, Swords R,

Kilcoyne A, Sankhala K, Mahalingam D, Padmnabhan S, Giles F; Leuk Lymphoma 2009 Feb; 50(2):

297-9

25. Deforolimus (AP23573) a novel mTOR inhibitor in clinical development. Expert Opin Investig Drugs.

2008 Dec; 17(12):1947-54; Mita M, Sankhala K, Abdel-Karim I, Mita A, Giles F.

26. Future options for imatinib mesilate-resistant tumors; Expert opinion on Investigational Drugs,

Volume 16, Number 10, October 2007, pp. 1549-1560(12); Sankhala, Kamalesh K; Papadopoulos,

Kyriakos P.

Abstracts 1. Longer term cardiac safety of aldoxorubicin. Sant P. Chawla, Kamalesh Sankhala, Scott Wieland,

Daniel J. Levitt; Sarcoma Oncology Center, Santa Monica, CA; CytRx Corporation, Los Angeles,

CA. J Clin Oncol 33, 2015 (suppl; abstr 10546)

2. Phase 2 study of gemcitabine, docetaxel, and doxorubicin in patients with advanced, unresectable,

and/or metastatic sarcoma who have failed prior therapies. Andrew Eugene Hendifar, Neal S Chawla,

Kamalesh Kumar Sankhala, Xiao Zhang, Doris V. Quon, Victoria S

Chua, Lita Fernandez, William E. Mendanha, Sant P. Chawla. J Clin

Oncol 33, 2015 (suppl; abstr 10573).

3. Sustained response of complex giant cell tumors with denosumab: Single center 8-year experience.

Neal Shiv Chawla, Susan V. Bukata, Kamalesh Kumar Sankhala, William E. Mendanha, Vivek

Narasimhan, Lawrence Menendez, Nicholas Bernthal, Earl W. Brien, Victoria S. Chua,

Sant P. Chawla. J Clin Oncol 33, 2015 (suppl; abstr 10528)

4. A phase Ib dose-escalation study of TRC105 (anti-endoglin antibody) in combination with pazopanib

in patients with advanced soft tissue sarcoma (STS). Steven Attia, Richard F. Riedel, Steven Ian

Robinson, Robert Martin Conry, Kamalesh Kumar Sankhala, Ben K. Seon, Delia Alvarez, Bonne J.

Adams, Charles P. Theuer, Robert G. Maki. J Clin Oncol 33, 2015

(suppl; abstr 10514)

5. A study of the safety and efficacy of the combination of gemcitabine and docetaxel with

ontuxizumab (MORAb-004) in metastatic soft tissue sarcoma. Sant P. Chawla, Patrick Schoffski,

Jean-Yves Blay, Robin Lewis Jones, Hans Gelderblom, Steven Attia, Bartosz Chmielowski, Brian

Andrew Van Tine, Jonathan C. Trent, Shreyaskumar Patel, Andrew J. Wagner, James Kert Viele,

Rashmi Chugh, Axel Le Cesne, Gabriel Tinoco, Kamalesh Kumar Sankhala, Julianne Falcone, Charles

Schweizer, Susan Weil, Robert G. Maki; J Clin Oncol 33, 2015 (suppl; abstr TPS10577)

6. Molecularly-guided therapeutic options beyond tyrosine kinase inhibitors (TKIs) for gastrointestinal

stromal tumors (GIST). Rebecca Feldman, Zoran Gatalica, Sandeep K. Reddy, Sant P. Chawla,

Kamalesh Kumar Sankhala; Caris Life Sciences, Phoenix, AZ; Caris Life Sciences, Irving, TX; Sarcoma

Oncology Center, Santa Monica, CA. J Clin Oncol 33, 2015 (suppl 3; abstr 58)

7. Randomized phase 2b trial comparing first-line treatment withaldoxorubicin versus doxorubicin in

patients with advanced soft tissue sarcomas. ASCO Abstract 2014, Abstract # 10502. Authors: Sant P.

Chawla, Zsuzsanna Papai, Kamalesh Sankhala, Leonid Vasylyev, Guzel Mukhametsina, Mamed Aliev,

Kenneth Khamly, Scott Wieland, Daniel J. Levitt.

8. 14-day continuous infusion ifosfamide in advanced refractory sarcomas. Arun S. Singh, Kamalesh

Kumar Sankhala, Arnob Mukherjee, Vivek Narasimha, Bartosz Chmielowski, Doris V. Quon, Vicky Chua,

Sant P. Chawla. J Clin Oncol 32:5s, 2014 (suppl; abstr 10596).

9. Phase Ib trial of combining aldoxorubicin plus doxorubicin. Kamalesh Kumar Sankhala, Sant P.

Chawla, Victoria S Chua, Doris Quon, Allison Bonk, Vivek Narasimhan, Monish Sodhi, Nina Krishna,

Hillary Dinh, Scott Wieland, Daniel Levitt; J Clin Oncol 31, 2013 (suppl; abstr 2550).

10. A phase I, first-in-human study to evaluate the safety, pharmacokinetics (PK), and

pharmacodynamics (PD) of IMGN853 in patients (Pts) with epithelial ovarian cancer (EOC) and other

FOLR1-positive solid tumors. Carla Kurkjian, Patricia LoRusso, Kamalesh Kumar Sankhala, Michael J.

Birrer, Maurice Kirby, Sharron Ladd, Susan Hawes, Kelli Lynn Running, James J. O'Leary, Kathleen N.

Moore. J Clin Oncol 31, 2013 (suppl; abstr 2573).

11. Phase Ib/II study of INNO-206 (EMCH-doxorubicin) in patients with soft tissue sarcoma. Sant P.

Chawla, Victoria S Chua, Andrew Hendifar, Doris Quon, Sandeep Nagre, Kristen N. Ganjoo, Kamalesh

Sankhala, Scott Wieland, Daniel Levitt; J Clin Oncol 30, 2012 (suppl; abstr 10036).

12. Amuvatinib (MP-470), an oral dual inhibitor of mutant kinases and DNA repair: Final results from a

100-patient, 5-arm phase Ib trial in combination with five standard of care (SOC) anticancer

regimens; K. K. Sankhala, A. W. Tolcher, M. M. Mita, M. S. Gordon, L. S. Rosen, K. P. Papadopoulos, A.

Patnaik, R. L. Drengler, A. C. Mita, J. Sarantopoulos, R. G. Bristow, G. Fine, G. S. Choy, M. Azab; J Clin

Oncol 29: 2011 (suppl; abstr 3074)

13. Phase I/II study of TH-302 in combination with docetaxel in patients with solid tumors including

NSCLC and castrate-resistant prostate cancer (CRPC). K. K. Sankhala, E. G. Chiorean, A. J.

Armstrong, M. J. Borad, A. M. Traynor, S. M. Gadgeel, V. K. Langmuir, C. Eng, S. Kroll, H. Burris;

Journal of Clinical Oncology (28), 2010 (suppl; abstr e13527)

14. Mammalian target of rapamycin (mTOR)-induced pneumonitis: Singleinstitution experience and

treatment; Y. Kahn, A. C. Mita, B. J. George, K. K. Sankhala, D. Mahalingam, K. R. Kelly, A. B. Karnad, J.

Sarantopoulos, M. M. Mita; Journal of Clinical Oncology (28), 2010 (suppl; abstr e13520)

15. Pralatrexate and Gemcitabine in Patients with Relapsed or Refractory Lymphoproliferative

Malignancies: Phase 1 Results; Steven M. Horwitz, Julie M. Vose, Ranjana Advani, Kamalesh Sankhala,

Swaminathan Padmanabhan, Paul A. Hamlin Jr, Andy Chen, Jasmine M Zain, Steven Fruchtman, and

Owen A O'Connor; 51st American Society of Hematology Annual Meeting, New Orleans, LA December

2009

16. Phase II Study of intravenous Reolysin (wild type reovirus) In patients with bone and soft tissue

sarcoma metastatic to lung; M Mita; K Sankhala; J Sarantopoulos; A Mita; A Carmona; S Goel; R

Chugh; K Mettinger; M Coffey; S Okuno; Connective Tissue Oncology Society, 15th annual meeting,

Novembe, 2009 Miami, FL.

17. A phase I pharmacokinetic (PK) study of MBP-426, a novel liposome encapsulated oxaliplatin; K. K.

Sankhala, A. C. Mita, R. Adinin, L. Wood, M. Beeram, S. Bullock, N. Yamagata, K. Matsuno, T. Fujisawa,

Phan; Journal of Clinical Oncology; 27:15s, 2009 (suppl; abstr 2535).

18. Interferons downregulate WT1 through the JAK/STAT pathway; Hima Bansal, Sanjay Bansal, Kamalesh

Sankhala, Manjeet Rao, Ronan Swords, Devalingam Mahalingam, Kevin Kelly, Jennifer Crew, Frank

Giles, Swaminathan Padmnabhan; American Association of Cancer Research Annual meeting April

2009, Colorado.

19. A Phase-II Study of Intravenous Reolysin (Wild Type Reovirus) in the Treatment of Patients with

Bone and Soft Tissue Sarcomas Metastatic to Lung; Monica Mita; Kamalesh Sankhala; Alain Mita; John

Sarantopoulos; Anthony Carmona; Sanjay Goel; Rashmi Chugh; Scott Okuno; Matt Coffey; George Gill;

Karl Mettinger; Connective Tissue Oncology Society November, 2008, London United Kingdom

20. Two phase I, pharmacokinetic (PK) and pharmacodynamic (PD) studies of TAS-109, a novel

nucleoside analogue with 14 days and 7 days continuous infusion schedules. K. K. Sankhala, C. H.

Takimoto, A. C. Mita, H. Xiong, J. Rodon, R. Adinin, K. Burns, T. Toko, K. Arakawa, S. Kopetz; Journal

of Clinical Oncology; 26: 2008 (May 20 suppl)

21. A phase II study of intravenous reolysin (wild-type reovirus) in the treatment of patients with bone

and soft tissue sarcomas metastatic to the lung; S. A. Soefje, J. Sarantopoulos, K. K. Sankhala, A. C.

Mita, J. J. Mahany, T. Carmona, M. Coffey, G. M. Gill, K. Mettinger, M. M. Mita; Journal of Clinical

Oncology; 26: 2008 (May 20 suppl)

22. First in human phase I study of BSI-201, a small molecule inhibitor of poly ADP-ribose polymerase

(PARP) in subjects with advanced solid tumors; S. Kopetz, M. M. Mita, I. Mok, K. K. Sankhala, J.

Moseley, B. M. Sherman, C. R. Bradley, A. W. Tolcher; Journal of Clinical Oncology; 26: 2008 (May 20

suppl; 3577).

23. Phase-1 Study of the Sphingomyelin/Cholesterol Liposome Formulation of Vinorelbine in Subjects

with Advanced Solid Tumors, Hodgkin’s disease, or Non-Hodgkin’s Lymphoma (NHL); S.M. Imperiale,

A.W. Tolcher, J. Sarantopoulos, G. Batist, K. Sankhala, J. Fontanilla-Gines, B. Lu, S. R. Deitcher, W.F.

Bleker; European Society for Medical Oncology Lugano, Switzerland, July 2008.

24. Phase I and pharmacokinetic study of a CanAg-targeted immunoconjugate, HuC242-DM4, in patients

with CanAg-expressing solid tumors; KK Sankhala, A Mita, A Ricart, MM Mita , C Lin, L Wood, J

Sarantopoulos, C Takimoto, A Patnaik , A Qin, S Zildjian, A Tolcher; AACR-NCI-EORTC International

Conference 2007: Molecular Targets and Cancer Therapeutics

25. A phase I and pharmacokinetic (PK) study of vinorelbine liposomes injection in patients with

advanced solid tumors, non-Hodgkin’s lymphoma, and Hodgkin’s disease; Gerald Batist, Anthony W.

Tolcher, John Sarantopoulos, Kamalesh Sankhala, Jeannie Fontanilla, Biao Lu, Gavin S. Choy, Steven

R. Deitcher; AACR-NCI-EORTC International Conference 2007: Molecular Targets and Cancer

Therapeutics

26. A phase I study of a CanAg-targeted immunoconjugate, huC242-DM4, in patients with Can Ag-

expressing solid tumors; M. M. Mita, A. D.Ricart, A. C. Mita, A. Patnaik, J. Sarantopoulos, K. Sankhala,

R. J. Fram, A. Qin, J. Watermill, A. W. Tolcher; Journal of Clinical Oncology, 2007 ASCO Annual

Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 3062.

27. Oblimersen can be administered by subcutaneous (SC) and brief intravenous (IV) infusion: Clinical

pharmacokinetics and pharmacodynamics (PK/PD) in patients with advanced cancer; C. Lin, K.

Papadopoulos, A. Patnaik, K. Sankhala, C. H. Takimoto, J. Rodon, T. Julian, B. D. Brown, A. W. Tolcher;

Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20

Supplement), 2007: 14083

28. Updated results of a phase II trial of AP23573, a novel mTOR inhibitor, in patients (pts) with

advanced soft tissue or bone Sarcomas; S. P. Chawla, A. W. Tolcher, A. P. Staddon, S. M. Schuetze, G.

Z. D'Amato, J. Y. Blay, K. K. Sankhala, S. T. Daly, V. M. Rivera, G. D. Demetri; June 2006; Journal of

Clinical Oncology, 2006 ASCO Annual Meeting Proceedings, Volume: Part I. Vol 24, No.1

29. Post-Ifosfamide therapy inflammation in musculoskeletal and soft-tissue sarcomas: Evaluation with F-

18 FDG PET and PET/CT, A. Iagaru, R. Masamed, K. K. Sankhala, S. Chawla, L. Menendez, A. Fedenko

and P. S. Conti; Society of Nuclear Medicine, Annual meeting, San Diego, 2006.

30. A Phase II Trial of AP23573, A Novel Mtor Inhibitor, in Patients with Advanced Soft Tissue or Bone

Sarcoma, Sant P Chawla, Anthony W Tolcher, Kamalesh K Sankhala, Arthur P Staddon, Camille L

Bedrosian, George D Demetri; November 2005; AACR-NCI-EORTC Annual International Conference

on Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications 2006,

Philadelphia, PA.

31. Updated Interim Results of A Phase 2 Study of The mTOR Inhibitor AP23573 In Patients With

Advanced Sarcomas of Soft Tissue or Bone, Sant P Chawla, Anthony W Tolcher, Kamalesh K

Sankhala, Arthur P Staddon, Camille L Bedrosian, George D Demetri; November 2005; Connective

Tissue Oncology Society (CTOS) 2005, Boca Raton, FL.

32. Early Imaging with [18F] 2-Fluoro-2-Deoxy-D-Glucose (FDG) Positron Emission Tomography (PET)

Scans as a Predictor of AP23573 Activity in Patients with Advanced Sarcomas; Kamalesh K Sankhala,

Sant P Chawla, Anthony W Tolcher, Vicky Chua, Sean T Daly, Camille L Bedrosian; November 2005;

Connective Tissue Oncology Society (CTOS) 2005, Boca Raton, FL.

33. Analysis of Potential Biomarkers of AP23573 Activity in a Phase II Trial in Sarcoma Patients, V.M.

Rivera, L. Berk, S.P. Chawla, S.T. Daly, K.K. Sankhala, T. Clackson, C.L. Bedrosian and G. D. Demetri.

November 2005; AACR-NCI-EORTC Annual International Conference on Molecular Targets and

Cancer Therapeutics: Discovery, Biology, and Clinical Applications 2005, Philadelphia, PA.

34. AP 23573: A Review of Recent Results. Sant P. Chawla, Kamalesh K. Sankhala, Monica M. Mita,

Anthony W. Tolcher; August 2005; The Electronic Sarcoma Update Newsletter, Vol. 2, No.4.

35. A phase II study of AP23573 (an mTOR inhibitor) in patients (pts) with advanced sarcomas, S. P.

Chawla, K. K. Sankhala, V. Chua, L. R. Menendez, F. C. Eilber, J. J. Eckardt, S. T. Daly, G. S. Rana, C. L.

Bedrosian, and G. D. Demetri; American Society of clinical oncology (ASCO), May 2005.

36. Early response evaluation of therapy with AP23573 (an mTOR inhibitor) in sarcoma using [18F]2-

fluoro-2-deoxy-D-glucose (FDG) positron emission tomography (PET) scan, K. K. Sankhala, S. P.

Chawla, A. Iagaru, R. Dellamaggiora, V. Chua, S. Daly, C. L. Bedrosian, G. K. Edwards, S. Cohen, and G.

D. Demetri; American Society of clinical oncology (ASCO), May 2005.

37. Role of Alpha-Interferon in reducing risk of metastasis and improving survival in patients with poor

prognosis Osteosarcoma, Sant P Chawla, Kamalesh K Sankhala, Ryan J DellaMaggiora, Victoria Chua,

Gary S Rana, Lawrence R Menendez, Jeffrey J Eckardt, and Earl Brian; November 2004; Connective

Tissue Oncology Society, (CTOS) Montreal, Quebec Canada.

38. Current Approaches of Medical Management in Breast Cancer, S.P.Chawla, K.K.Sankhala, and

R.Dellamagiora; International Cancer Congress 2004, New Delhi, March 2004.

39. Management of Small Cell Lung Cancer (SCLC) - Limited Disease, K.K.Sankhala, and A.K.Vaid,

Volume: 6 No. 9; October 2003; Rajiv Gandhi Cancer Institute and Research Center 7th Anniversary

Issue of Newsletter.

40. Breast Cancer in the Elderly: A Retrospective Study, Sankhala K.K, Doval D.C., Vaid A.K., Lokanatha

K., Talwar, V., Sharma J.B., and Pande S.B., March 2003; Abstract & Souvenir Book, 2nd International

conference of Rajiv Gandhi Cancer Institute and Research Center, New Delhi.

Studies worked as Principal and Co-Principal Investigator at Institute for Drug

Development, CTRC at University of Texas Health Science Center San Antonio and at

Sarcoma Oncology center:

1. A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and

Maximum Tolerated Dose AP 23573, when Administered Orally in Patients with refractory or

Advanced Malignancies.

2. A Pivotal Trial to Determine the Efficacy and Safety of AP 23573 when Administered as Maintenance

Therapy to Patients with Metastatic Soft-Tissue or Bone Sarcomas

3. A phase 1A open label, dose escalation study of BQS481 administered intravenously to adult patients

with advanced solid tumors.

4. A Phase I Trial of Deforolimus (AP 23573; MK-8669), an mTOR Inhibitor, in Combination with

Bevacizumab for Patients with Advanced Cancers.

5. A Phase I Study To Assess the Safety and Pharmacokinetics of huC242-DM4 Administered as a Single

Intravenous Infusion Once Every Three Weeks to Subjects with Solid Tumors

6. A Phase II, Multi Center, Parallel group, Randomized Study of Palfosfamide with Doxorubicin Versus

Doxorubicine in Subjects with Unresectable or metastatic Soft-Tissue Sarcoma (PICASSO)

7. A Phase I Multicenter, Open Label, Dose Escalation Trial of (R763 given orally to Subjects with solid tumors.

8. A Phase II Study of Intravenous REOLYSIN (Wild-Type Reovirus) in the Treatment of Patients with

Bone and Soft Tissue Sarcomas Metastatic to the Lung

9. A Study to Determine the Activity of SCH717454 in Subjects with Osteosarcoma or Ewing’s Sarcoma

That Has Relapsed After Standard Systemic Therapy

10. A Phase I Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of the

Cyclin Dependent Kinase (CDK) Inhibitor SCH727965 Administered Every 3 Weeks in Patients with

Advanced Malignancies.

11. Phase I, Open Label, Multi-Center Study of TAS-109 Given by continuous intravenous 7-day Infusion

in Patients with Advanced or Metastatic Solid Tumors.

12. A Phase I Study of Vinorelbine Liposomes Injection (VLI) for Treatment in Patients with Advanced

Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease.

13. Open label, Phase-I Study to determine the safety, tolerability, maximum tolerated dose,

pharmacokinetics and biomarker status of BAY 73-4506 in patients with advanced malignancies.

14. An open label, Dose-Escalation and Pharmacokinetic Study of AVE9633 Administered as a single

agent by intravenous infusion on Day 1, Day 4 and Day 7 of a 4-week cycle in patients with relapsed

or refractory CD-33 Positive Acute Myeloid Leukemia (AML).

15. A Phase I Study of the Vascular Disrupting Agent NPI-2358 Administered via intravenous infusion in

Patients with Advanced Solid Tumor Malignancies or Lymphoma.

16. A phase I pharmacokinetic (PK) study of MBP-426, a novel liposome encapsulated oxaliplatin in

Patients with advanced solid tumors.

17. A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic

Liposarcoma.

18. An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Tumor of Bone.

19. A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and

Pharmacodynamics of AMG 232 in Adult Subjects with Advanced Solid Tumors.

20. An open-label Phase I dose-escalation study to characterize the safety,tolerability, pharmacokinetics,

and maximum tolerated dose of oral BAY 1161909 in combination with weekly intravenous paclitaxel

given in an intermittent dosing schedule in subjects with advanced malignancies.

21. An open-label randomized two-arm Phase I dose-escalation study to characterize thesafety,

tolerability, pharmacokinetics, and maximum tolerated dose of oral BAY 1217389 in combination with

weekly intravenous paclitaxel given in an intermittent dosing schedule in subjects with advanced

malignancies.

22. A Registry of Caris Life Sciences Molecular Intelligence Service (Biomarker Assessment Results)

Intended for Correlation with Cancer Clinical Outcomes.

23. An Open-Label Phase 1b Study to Investigate the Preliminary Safety and Activity of Aldoxorubicin

plus Gemcitabine in Subjects with metastatic Solid Tumors.

24. An Open-Label Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of

Aldoxorubicin in Subjects with Unresectable Glioblastoma Whose Tumors Have Progressed Following

Prior Treatment with Surgery, Radiation and Temozolomide.

25. A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of

Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or

Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant

Chemotherapy.

26. 26.An Open-Label Phase 1/2 Study to Investigate the Preliminary Safety and Activity of

Aldoxorubicin plus Ifosfamide/Mesna in Subjects with Metastatic, Locally Advanced, or Unresectable

Soft Tissue Sarcoma.

27. A multi-center single agent Phase II study of the efficacy of nilotinib in patients with relapsed or

metastatic pigmented villonodular synovitis/tenosynovial giant cell tumor/diffuse-type giant cell

tumor

28. Randomized, open-label, multicenter, Phase 3 study to compare the efficacy and safetyof Eribulin

with Dacarbazine in subjects with soft tissue sarcoma. A Prospective Observational Study to

Examine,in Routine Clinical Practice in the US, Practice Patterns and Impact on Clinical Decision

Making Associated with the FoundationOne Next Generation Sequencing (NGS) Test .

29. A Phase II study of Amrubicin Chemotherapy as First Line Treatment in Patients with Metastatic or

Unresectable Soft Tissue Sarcoma.

30. A Phase 1b Study Evaluating the Safety, Tolerability and Immunogenicity of CMB305 (Sequentially

Administered LV305 and G305) in Patients with Locally Advanced, Relapsed, or Metastatic Cancer

Expressing NY-ESO-1.

31. A randomized controlled study of Yondelis (Trabectedin) or Dacarbazine for the treatment of

advanced liposarcoma or leiomyosarcoma.

32. A multicenter, open label, single arm study of Yondelis (Trabectedin) for subjects with locally

advanced or metastatic soft tissue sarcoma who have relapsed or are refractory to standard care

treatment.

33. A Randomized, Open-label, Phase II, Multi-center Trial of Gemcitabine (G) with Pazopanib (P) or

Gemcitabine (G) with Docetaxel (T) in Previously Treated Subjects with Advanced Soft Tissue Sarcoma.

34. Phase 1b/2 Study of Vorinostat in Combination with Gemcitabine and Docetaxel in

Advanced Sarcoma.

35. A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel with MORAb-

004 in Metastatic Soft Tissue Sarcoma.

36. A Phase II Trial in Which Patients With Metastatic Alveolar Soft Part Sarcoma Are Randomized to

Either Sunitinib or Cediranib Monotherapy, With Cross-Over at Disease Progression.

37. A Phase II Combination immunotherapy with Herceptin and the HER2 vaccine E75 in low and

intermediate HER2-expressing breast cancer patients to prevent recurrence.

38. Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 1 -

BKM120 for patients with P13k-activated tumors.

39. Modular phase study to link targeted therapy to patients with pathway activated tumors: Module 2 -

Dovitinib for patients with tumor pathway activations inhibited by dovitinib including tumors with

mutations or translocations of FGFR, PDGFR, VEGF, cKIT, FLT3, CSFR1, Trk and RET.

40. Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 4

- LGX818 for patients with BRAFV600 mutated tumors.

41. Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 8

– LEE011 for patients with CDK4/6 pathway activated tumors.

42. Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 7

– Ceritinib (LDK378) for patients whose tumors have aberrations in ALK or ROS1.

43. A First-in-Human Phase 1, Dose Escalation, Safety and Pharmacokinetic Study of PF-06647263 in

Adult Patients with Advanced Solid Tumors.

44. Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade

Malignant Peripheral Nerve Sheath Tumors.

45. TRUSTS: A phase IIb/III multicenter study comparing the efficacy of TRabectedin administered as a

3-hour or 24-hour infusion to doxorubicin in patients with advanced or metastatic Untreated Soft

Tissue Sarcoma.

46. A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional Phase II.5 Study of AZD0530,

a Selective Src Kinase Inhibitor, In Patients with Recurrent Osteosarcoma Localized to the Lung.

47. A Phase I/II Trial of ganetespib in combination with the mTOR inhibitor sirolimus for patients with

unresectable or metastatic malignant peripheral nerve sheath tumors.

48. SARC024: A blanket protocol to study oral regorafenib in patients with refractory liposarcoma,

osteogenic sarcoma, and Ewing/Ewing–like sarcomas.

49. A Phase 2, Single Center, Open Label Study to Determine the Safety and Efficacy of 14 Day

Continuous Infusion Ifosfamide in Patients with Locally Advanced, Unresectable and/or Metastatic

Sarcoma.

50. A Phase 2, Single Center, Open Label Study to Determine the Safety and Efficacy of Combination of

Low Dose Gemcitabine, Doxorubicin, and Docetaxel in Patients with Advanced, Metastatic and/or

Unresectable Sarcoma.

51. A Phase 1/2 maximum tolerated dose study of Belinostat (PXD-101) in combination with Paclitaxel

plus Carboplatin in chemotherapy-naïve patients with Stage IV non-small-cell lung cancer (NSCLC).

52. A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH- 302 in Combination with

Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft

Tissue Sarcoma.

53. A Phase 1B Dose-Escalation Study of TRC105 in Combination with Pazopanib in Patients with

Advanced Soft Tissue Sarcoma.

54. A Phase 1/2 Study of FPA008, an Anti-CSF1 Receptor Antibody, in Patients With Pigmented

Villonodular Synovitis (PVNS)/ Diffuse Type Tenosynovial Giant Cell Tumor (Dt-TGCT).

55. A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors.

56. A Phase 2 Multi-center Investigation of Efficacy of ABI-009 (nabrapamycin) in Patients with

Advanced Malignant Perivascular Epithelioid Cell Tumors (PEComa)

57. A Phase 3, Multicenter, Randomized, Double-blind, Active Control Study to Evaluate the Safety and

Efficacy of IV Pronetupitan/palonosetron (260 mg/0.25 mg) combination for the Prevention of

Chemotherpy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles in Patients Receiving

Highly Emetogenic Chemotherapy.

58. A Phase 2-3 Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in

Patients with Advanced Unresectable Dedifferentiated Liposarcoma (DDLS).

59. A Phase 1b Study Evaluating the Safety, Tolerability and Immunogenicity of CMB305 (Sequentially

Administered LV305 and G305) in Patients with Locally Advanced, Relapsed, or Metastatic Cancer

Expressing NY-ESO-1.

60. An Open-label, Multicenter, Global, Phase 2 Basket Study of Entrectinib for the Treatment of Patients

with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1 or ALK Gene

Rearrangements.

61. Randomized Phase IIB Trial of VigilTM (bi-shRNA furin and GMCSF Augmented Autologous Tumor

Cell Immunotherapy) versus Gemcitabine + Docetaxel for Ewing's Sarcoma.

62. A Phase I, Multicenter, Open-label, Drug-Drug Interaction Study to Assess the Effect of Ceritinib on

the Pharmacokinetics of Warfarin and Midazolam Administered as a Two-Drug Cocktail in Patients

with ALKpositive Advanced Tumors Including Non-Small Cell Lung Cancer (NSCLC).