rhe cv 2015 - microsoft · 2017. 3. 22. · high school: handley high school, winchester, va...

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Robert H. Earhart, Jr., M.D., Ph.D. Page 1 Curriculum Vitae CURRICULUM VITAE Robert Howard Earhart, Jr., M.D., Ph.D. ADDRESS: Home: 13098 Manzanita Road NE Bainbridge Island, WA 98110 Phone: (206) 780-3555 Cell: (240) 447-3173 EDUCATION: High School: Handley High School, Winchester, VA 1959-1960 Western Reserve Academy, Hudson, OH 1960-1963 Undergraduate: Northwestern University, Evanston, IL 1963-1965 Degree: B.S. (Medicine) (1966) Graduate: (1) Northwestern University Medical School 1965-1967 and 1970-1972; Degree: M.D. (1972) (2) Northwestern University Graduate School 1967-1970; Degree: Ph.D. (1975) Dissertation: Ph.D. Dissertation, "Studies on the Mechanism of Action of Diels-Alder Adducts of Polycyclic Aromatic Hydrocarbon Carcinogens” R. H. Earhart, Northwestern University, August 1975. PROFESSIONAL TRAINING: Internship, Straight Internal Medicine University of Michigan Affiliated Hospitals 1972-1973 Residency, Internal Medicine University of Michigan Affiliated Hospitals 1973-1975 Special Scholar in Internal Medicine and Postdoctoral Fellow in Pharmacology, University of Michigan 1975-1976 TEACHING APPOINTMENTS: Instructor in Internal Medicine and Pharmacology University of Michigan 1976-1978 Assistant Professor, Department of Human Oncology 1 of 16 Celltrion, Inc., Exhibit 1002

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Page 1: RHE CV 2015 - Microsoft · 2017. 3. 22. · High School: Handley High School, Winchester, VA 1959-1960 Western Reserve Academy, Hudson, OH 1960-1963 Undergraduate: Northwestern University,

Robert H. Earhart, Jr., M.D., Ph.D. Page 1 Curriculum Vitae

CURRICULUM VITAE

Robert Howard Earhart, Jr., M.D., Ph.D. ADDRESS: Home: 13098 Manzanita Road NE Bainbridge Island, WA 98110 Phone: (206) 780-3555 Cell: (240) 447-3173 EDUCATION: High School: Handley High School, Winchester, VA 1959-1960 Western Reserve Academy, Hudson, OH 1960-1963 Undergraduate: Northwestern University, Evanston, IL 1963-1965 Degree: B.S. (Medicine) (1966) Graduate: (1) Northwestern University Medical School 1965-1967 and 1970-1972; Degree: M.D. (1972) (2) Northwestern University Graduate School 1967-1970; Degree: Ph.D. (1975) Dissertation: Ph.D. Dissertation, "Studies on the Mechanism of Action of Diels-Alder

Adducts of Polycyclic Aromatic Hydrocarbon Carcinogens” R. H. Earhart, Northwestern University, August 1975.

PROFESSIONAL TRAINING: Internship, Straight Internal Medicine University of Michigan Affiliated Hospitals 1972-1973 Residency, Internal Medicine University of Michigan Affiliated Hospitals 1973-1975 Special Scholar in Internal Medicine and Postdoctoral Fellow in Pharmacology, University of Michigan 1975-1976 TEACHING APPOINTMENTS: Instructor in Internal Medicine and Pharmacology University of Michigan 1976-1978 Assistant Professor, Department of Human Oncology

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Robert H. Earhart, Jr., M.D., Ph.D. Page 2 Curriculum Vitae University of Wisconsin 1978-1982 Assistant Professor, School of Pharmacy University of Wisconsin 1979-1982 Clinical Assistant Professor, Dept. of Internal Medicine Wayne State University Medical School 1984-1990 PRESENT STATUS: Clinical Research Physician II Nov. 1982 - Nov. 1984 Clinical Research Manager Dec. 1984 - Jan. 1992 Associate Clinical Research Director Feb. 1992 - April 1995 The Upjohn Company, Kalamazoo, Michigan Associate Director, Oncology Medical Affairs May 1995 – Sept 1999 Rhône Poulenc Rorer Pharmaceuticals Inc, Collegeville, PA Senior Director, Clinical Research Oct 1999 – Dec 1999 U.S. Bioscience, Inc, West Conshohocken, PA Vice President, Clinical Development Jan 2000 – Oct 2002 MedImmune Oncology, Inc, Gaithersburg, MD Vice President, Global Medical Affairs Apr 2003 – Aug 2005 Cell Therapeutics, Inc, Seattle, WA Principal Member Aug 2005 – Feb 2008 Arrowsmith Oncology LLC, Bainbridge Island, WA Senior Director, Clinical Development Mar 2008 – Feb 2010 Poniard Pharmaceuticals, Inc, Seattle, WA Principal Member Mar 2010 – present Arrowsmith Oncology LLC, Bainbridge Island, WA SOCIETIES: American Society for Clinical Oncology American Association for Cancer Research American Society for Clinical Pharmacology and Therapeutics

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Robert H. Earhart, Jr., M.D., Ph.D. Page 3 Curriculum Vitae MEDICAL LICENSURE: Michigan #32151, December 1982 BOARD CERTIFICATION: American Board of Clinical Pharmacology #91406, August 1991 HOSPITAL STAFF APPOINTMENTS: Dept. of Internal Medicine, University of Michigan Hospitals and Clinics 1976-1978 Dept. of Human Oncology, University of Wisconsin Hospital 1978-1982 Internal Medicine Staff, Bronson Hospital, Kalamazoo, MI 1983-1995 Internal Medicine Consulting Staff, Borgess Hospital, 1984-1995 Kalamazoo, MI AWARDS: American Cancer Society Combined Degree Fellowship Northwestern University 1968-1972 The Upjohn Company Postdoctoral Fellowship in Clinical Pharmacology of Antineoplastic Agents 1975-1976 Junior Faculty Clinical Fellow (JFCF #388) American Cancer Society 1977-1980 REVIEWER FOR: Cancer Research Cancer Treatment Reports Journal of the Parenteral Drug Association Medical Letter American Journal of Medicine Medical and Pediatric Oncology Annals of Internal Medicine New England Journal of Medicine Investigational New Drugs Cancer Chemotherapy and Pharmacology NATIONAL AND INTERNATIONAL BOARDS AND COMMITTEES: Steering Group, New Agents and Pilot Studies Committee, Eastern Cooperative Oncology Group, June 1977-1989.

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Robert H. Earhart, Jr., M.D., Ph.D. Page 4 Curriculum Vitae Chairman, Pharmacology Subcommittee, NAPSC, ECOG, June 1980-November 1982. Consultant, Eastern Cooperative Oncology Group, June 1977-1989. Consultant, Southwest Oncology Group, Sept 1984-1990 Member, Oncology Working Group, International Federation of Pharmaceutical Manufacturers' Associations, October 1983 - 1995. Member, Ethics Committee, American Association of Pharmaceutical Physicians, 1998 - 1999 STATE BOARDS AND COMMITTEES: Consultant, WCCC Cancer Information Service, September 1978-November 1982. Member, University of Wisconsin Pain Management Team, September 1980- November 1982. Member, Clinical Affairs Committee, Wisconsin Clinical Cancer Center, June 1980-November 1982. Member, Laboratory Advisory Committee, Wisconsin Clinical Cancer Center, June 1980-November 1982. Member, Curriculum Subcommittee, LAC, Department of Human Oncology, September 1980-November 1982. Course Chairman, Pharmacology of Anticancer Drugs, University of Wisconsin Graduate School, September 1979-November 1982. Member, Pharmacy and Therapeutics Committee, University of Wisconsin Hospital, June 1981-November 1982. Chairman, Drug Education Subcommittee, University of Wisconsin Hospital, June 1982-November 1982. GRANT SUPPORT: Principal Investigator: Pfizer Central Research Grant, "Double-blind Comparison of Levonantradol and Prochlorperzine," $24,012, February 1981-October 1982. Coinvestigator: NIH (NCI) Contract NCI-CM-27509-19; Principal Investigator, Dr. Douglass C. Tormey; entitled "Phase I Studies of New Anticancer Agents," $508,103. PATENTS:

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Robert H. Earhart, Jr., M.D., Ph.D. Page 5 Curriculum Vitae McGovren, JP, Williams, MG, and Earhart, RH. Preventing CNS Toxicity of Acivicin When Used With Four Large Neutral Amino Acids. Patent #3,087,639, Granted 11 February 1992 Phillips, AF, Earhart, RH Jr, Perry MS. High Bioavailability Oral Picoplatin Anti-Cancer Therapy. PCT/US2010/000735. Priority Date 15 April 2009

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Robert H. Earhart, Jr., M.D., Ph.D. Page 6 Curriculum Vitae PUBLICATIONS: Original Observations in Refereed Journals: 1. Stern PH, Earhart RH. Role of Citrate, Lactate, Pyruvate, and Fatty Acids in Albumin-

Induced Bone Resorption. Proc Soc Exp Biol Med 1971;139:981- 4 2. Sullivan TJ, Hallmark MR, Sakmar E, Weidler DJ, Earhart RH, Wagner JG. Comparative

Bioavailability: Eight Commercial Prednisone Tablets. J Pharmacokinet Biopharm 1976;4(2):157-172

3. Wilkinson PK, Sedman AJ, Sakmar E, Earhart RH, Weidler DJ, Wagner JG. Blood

Ethanol Concentrations During and Following Constant-Rate Intravenous Infusion of Alcohol Clin Pharmacol Therap 1976;19:213-223

4. Earhart RH. Instability of cis-dichlorodiammine Platinum (II) in Dextrose Solutions.

Cancer Treat Rep 1978;62:1105 5. Wheeler RH, Liepman MK, Baker SR, Earhart RH, Bull FE, Ensminger WD. Bleomycin,

Oncovin, Mitomycin C, and Methotrexate (BOMM) in Squamous Cell Carcinoma. Cancer Treat Rep 1980;64:943-9

6. Koeller JM, Earhart RH, Davis, HL. Phase I Trial of ICRF-187 (NSC-169780) by 48-

Hour Continuous Infusion. Cancer Treat Rep 1981;65:459-63 7. Earhart RH, Koeller JM, Davis HL. Phase I Trial of PCNU (NSC-95466) Administered by

5-Day Courses. Cancer Treat Rep 1981;65:835-40 8. Leopold WR, Batzinger RP, Miller EC, Miller JA, Earhart RH. Mutagenicity,

Tumorigenicity, and Electrophilic Reactivity of the Stereoisomeric Platinum (II) Complexes of 1,2-diaminocyclohexane. Cancer Res 1981;41:4368-77

9. Earhart RH, Koeller JM, Davis, HL. Phase I Trial of 6-diazo-5-oxo-L-norleucine (NSC-

7365) Administered by 5-Day Courses. Cancer Treat Rep 1982;66:1215-17 10. Earhart RH, Tutsch KD, Koeller JM, Rodriguez R, Robins HI, Vogel CL, Davis HL,

Tormey DC. Pharmacokinetics of (+)-1,2-Di(3,5-dioxopiperazin-1-yl)propane Intravenous Infusion in Adult Cancer Patients. Cancer Res 1982;42:5255-61

11. Earhart RH, Elson PJ, Rosenthal S, Hahn RG, Slayton, RE. Phase II Study of PALA and

AMSA in Advanced Renal Cell Carcinoma. Amer J Clin Oncol 1983;6:555-60 12. Earhart RH, Martin PA, Tutsch KD, Erturk E, Wheeler RH, Bull FE. Improvement in the

Therapeutic Index of Cisplatin (NSC-119875) by Pharmacologically Induced Chloruresis in the Rat. Cancer Res 1983;43:1187-94

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Robert H. Earhart, Jr., M.D., Ph.D. Page 7 Curriculum Vitae 13. Earhart RH, Koeller JM, Davis TE, Borden EC, McGovren JP, Tormey DC, Davis HL.

Phase I Trial and Pharmacokinetics of Acivicin (NSC-163501) Administered by 72-Hour Infusion. Cancer Treat Rep 1983;67:683-92

14. Earhart RH, Moertel C, Ramirez G, Woodhouse C. Phase II Trial of PCNU in Advanced

Colorectal Carcinoma. Am J Clin Oncol 1984;7:309-12 15. Ettinger DS, Tritchler D, Earhart R, Creech RH. Phase II Study of PALA and PCNU in

the Treatment of Non-Small Cell Lung Cancer (EST 2580): An Eastern Cooperative Oncology Group Study. Cancer Treat Rep 1984;68:1297-98

16. Weingart WA, Sorkness CA, Earhart RH. Analgesia with Oral Narcotics and Added

Ibuprofen in Cancer Patients. Clinical Pharmacy 1985;4:53-8 17. Earhart RH, Muggia F, Golumb F. Phase II Trial of PCNU in Advanced Melanoma.

Investigational New Drugs 1985;3:297-301 18. Holcenberg JS, Tutsch KD, Earhart RH, Underleider RS, Kamen BA, Pratt CB, Gribble

TJ, Glaubiger DL. Phase I Study of ICRF-187 in Pediatric Cancer Patients and Comparison of Its Pharmacokinetics in Children and Adults. Cancer Treat Rep 1986;70:703-9

19. Koeller JM, Trump DL, Tutsch KD, Earhart RH, Davis TE, Tormey, DC. Phase I Clinical

Trial and Pharmacokinetics of Carboplatin (NSC 241240) by Single Monthly Thirty Minute Infusion. Cancer 1986;57:222-5

20. Dodion P, Sessa C, Joss R, Crespeigne N, Willems Y, Kitt M, Abrams J, Finet C, Brewer

JE, Adams WJ, Earhart RH, Rozencweig M, Kenis Y, Cavalli F. Phase I Study of Intravenous Menogaril Administered Intermittently. J Clin Oncol 1986;4:767-74

21. Elson PJ, Earhart RH, Kvols LK, Spiegel R , Keller AM, Kies MS, Davis TE, Stevens C,

Gumas L, Trump DL. Phase II Studies of PCNU and Bisantrene in Advanced Renal Cell Carcinoma. Cancer Treat Rep 1987;71:331-2

22. Willson JKV, Fischer PH, Tutsch KD, Alberti D, Simon K, Hamilton RD, Bruggink J,

Koeller JM, Tormey DC, Earhart RH, Ranhosky A, Trump DL. Phase I Clinical Trial of a Combination of Dipyridamole and Acivicin Based upon Inhibition of Nucleoside Salvage. Cancer Res 1988;48:5585-90

23. Earhart RH, Faraggi D, Khandekar JD, Schinella R, Davis TE. Phase II Trial of

Continuous Drug Infusions in Advanced Ovarian Carcinoma: Acivicin Versus Vinblastine. Investigational New Drugs 1989;7:255-60

24. Stewart DJ, Maroun JA, Verma S, Perrault D, Earhart RH. Phase I Study of Weekly

Intravenous Administration of Menogaril to Adults with Solid Tumors. Am J Clin Oncol 1989;12:511-18

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Robert H. Earhart, Jr., M.D., Ph.D. Page 8 Curriculum Vitae 25. Earhart RH, Amato DA, Chang AY, Borden EC, Shiraki M, Dowd ME, Comis RL, Davis

TE, Smith TJ. Phase II Trial of 6-Diazo-5-Oxo-1-Norleucine Versus Aclacinomycin-A in Advanced Sarcomas and Mesotheliomas. Investigational New Drugs 1990;8:113-9

26. Stewart DJ, Verma S, Maroun JA, Robillard L, Earhart RH. Phase I Study of Oral

Menogaril Administered on a Once Weekly Schedule. Investigational New Drugs 1990;8:43-52

27. Whitehead RP, Earhart RH, Fleming T, Goodman P, Macdonald JS, Pollock T,

Ungerleider JS. A Phase II Study of Menogaril (NSC-269148) in Colorectal Carcinoma: A Southwest Oncology Group Study. Investigational New Drugs 1990;8:295-7

28. Williams MG, Earhart RH, Bailey H, McGovren JP. Prevention of Central Nervous

System Toxicity of the Antitumor Antibiotic Acivicin by Concomitant Infusion of an Amino Acid Mixture. Cancer Research 1990;50:5475-80

29. Sarosdy MF, Lamm DL, Williams RD, Moon TD, Flanigan RC, Crawford ED, Wilks NE,

Earhart RH, Merritt JA. Phase I Trial of Oral Bropirimine in Superficial Bladder Cancer. J Urology 1992;147:31-3

30. Stewart DJ, Aitken SE, Verma S, Maroun JA, Robillard L, Touchie M, Prosser IA, Earhart

R. Phase I study of oral menogaril administered daily for 14 consecutive days. Ann Oncol 1992;3(5):401-3

31. Stewart DJ, Hugenholtz W, DaSilva VF, Benoit BG, Richard MT, Verma S, Earhart RH,

Robillard L. Phase II Study of Weekly Intravenous Menogaril in the Treatment of Recurrent Astrocytomas in Adults. J Neuro-Oncology 1992;13:183-8

32. Stewart DJ, Grewaal D, Green RM, Goel R, Mikhael N, Montpetit VAJ, Redmond D,

Earhart RH. Human-autopsy tissue distribution of menogaril and its metabolites. Cancer Chemother Pharmacol 1993;32:373-8

33. Weiss GR, Brown TD, Kuhn JG, VonHoff DD, Earhart RH, Adams WJ, Brewer JE,

Hosley JD, Kasunic, DA. A Phase I Clinical and Pharmacokinetic Study of the Oral and the Oral/Intravenous Administration of Menogaril. Investigational New Drugs 1993;11:17-27

34. Fleming GF, Ratain MJ, O'Brien SM, Schilsky RL, Hoffman PC, Richards JM, Vogelzang

NJ, Kasunic DA, Earhart RH. Phase I Study of Adozelesin by 24-Hr Continuous Infusion. JNCI 1994;86:368-72

35. Shamdas GJ, Alberts DS, Modiano M, Wiggins C, Power J, Kasunic DA, Earhart RH.

Phase I Study of Adozelesin (U-73,975) in Patients with Solid Tumors. Anti-Cancer Drugs 1994;5:10-4

36. Welch DR, Aeed PA, Earhart RH, McClure SA. Evidence for Paracrine Regulation of

Experimental Metastasis in 13762NF Rat Mammary Adenocarcinoma Cell Clones. Anticancer Research 1994;14: 1743-52

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Robert H. Earhart, Jr., M.D., Ph.D. Page 9 Curriculum Vitae 37. Burris HA, Dieras VC, Tunca M, Earhart RH, Eckardt JR, Rodriguez GI, Shaffer DS,

Fields SM, Campbell E, Schaaf L, Kasunic DA, Von Hoff DD. Phase I study with the DNA sequence-specific agent adozelesin. Anticancer Drugs 1997;8:588-96.

38. Foster BJ, LoRusso PM, Poplin E, Zalupski M, Valdivieso M, Wozniak A, Flaherty L,

Kasunic DA, Earhart RH, Baker LH. Phase I trial of Adozelesin using the treatment schedule of daily x 5 every 3 weeks. Investigational New Drugs 1996;13:321-6.

39. Valero V, Jones SE, Von Hoff DD, Booser DJ, Mennel RG, Ravdin PM, Holmes FA,

Rahman Z, Schottstaedt MW, Erban JK, Esparza-Guerra L, Earhart RH, Hortobagyi GN, Burris HA III. A Phase II Study of Docetaxel in Patients with Paclitaxel-resistant Metastatic Breast Cancer. J Clin Oncol 1998;16:3362-8.

40. Belani CP, Einzig A, Bonomi P, Dobbs T, Capozzoli MJ, Earhart R, Cohen LJ.

Multicenter Phase II Trial of Docetaxel and Carboplatin in Patients with Stage IIIB and IV Non-Small-Cell Lung Cancer. Ann Oncol. 2000;11:673-8.

Review Articles: 1. Mischler, NE, Earhart, RH, Carr, B and Tormey, DC. Dibromodulcitol. Cancer Treat Rev

1989;6:191-204 2. Earhart, RH and Buchanan-Davidson, DJ. Tetrahydrocannabinol as an antiemetic for

Cancer Patients. Wis Med J 1980;79: 47-8 3. Earhart, RH and Neil, GL. Acivicin in 1985. Adv. Enzyme Reg 1986;24:179-205 4. McGovren, JP, Adams, WJ, and Earhart, RH. Menogaril Pharmacology and Phase I/II

Clinical Trial. p.p. 629-666. In: Anthracyclines and Anthraquinone - Based Anticancer Agents, J.W.Lown (Ed.), Elsevir Science Publishers, Amsterdam, (1988).

5. Earhart, RH. Taxotere: Preclinical and General Clinical Information. Seminars in

Oncology, 1999. Books and Chapters: 1. Earhart, RH. Cancer of the Ovary. In: Concepts in Cancer Medicine, S.B. Kahn, R.R.

Love, and C.S. Sherman (Eds.), FW Davis, Inc., Philadelphia (1982). 2. Earhart, RH. Acivicin: A New Antimetabolite. In Cancer Chemotherapy III, F. Muggia

(Ed.) Martinus Nijhoff Publishers, Boston, (1987). 3. Adams, WJ, Hosley, JD, McGovren, JP, Smith, TC and Earhart, RH. Absorption of

Antineoplastic and Antihypertension Drugs. In Proceedings of the PMA/FDA Meeting on the Use of Animals as Substitutes for Humans in Oral Bioavailability Studies.

Case Reports:

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Robert H. Earhart, Jr., M.D., Ph.D. Page 10 Curriculum Vitae 1. Earhart, RH, DeConti, RC, Rubin, J and Ohnuma, T. Response of Psoriasis to N-

Phosphonacetyl-L-aspartate. Lancet, 1257-1258 (June 6, 1981). 2. Kuebler, JP, Earhart, R and Hafez, GR. Chemotherapy-Induced Remission in a Patient

With Small Cell Carcinoma of the Lung and Hairy Cell Leukemia. Cancer 1985;55:2758-60

Non-scientific Essays: 1. Earhart, RH. The Franciscan Who Taught Me Haecceitas. The Way of St Francis.

2012; 18(6): 15-25. 2. Earhart, RH. I Love, Therefore I Believe: A Meditation on Affinity. The Way of St

Francis. 2013:19(3):24-31 Educational Materials: Lucchesi, BR, Zannoni, VG, Swain, HH and Earhart, RH. Pharmacology and Therapeutics: A Workbook. Media Library, University of Michigan (1977). Webinars: Essential Basics: Introduction to Oncology Best Laid Plans: Product Development Plans in Oncology Cancer is Different: Clinical Trials in Oncology Drug Development Avoiding Sudden Death: QTc Studies in Oncology Doing It Right: Ethics in Oncology Drug Development Pancreatic Cancer: The Disease and Its Treatment Renal Cancer: The Disease and Its Treatment Lectures Presented (2010-2016): Overview of Pharmacokinetics (7 lectures) Introduction to Oncology Principles of Cancer Biology Principles of Cancer Pharmacology Principles of Oncology Clinical Trials in Oncology: Phase I* Clinical Trials in Oncology: Phase II* Clinical Trials in Oncology: Phase III* Clinical Development Plans in Oncology FDA Regulatory Aspects of Oncology Drug Development Oncology Clinical Operations A Tour of the Cancer Biomarker Space Biomarker Regulatory Issues Biomarkers and Clinical Trials in Oncology Tumor Immunology Immuno-oncology (8 lectures)

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Robert H. Earhart, Jr., M.D., Ph.D. Page 11 Curriculum Vitae Medical Ethics in Oncology Drug Development Ovarian Cancer: The Disease and Its Treatment Understanding Ovarian Cancer: Basic Background Understanding Ovarian Cancer: Standard Therapy Understanding Ovarian Cancer: Research Issues Gynecologic Cancers (Ovarian, Endometrial and Cervical) Renal Cancer: The Disease and Its Treatment Head and Neck Cancer: The Disease and Its Treatment Melanoma: The Disease and Its Treatment Lung Cancer: The Disease and Its Treatment *often combined

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Robert H. Earhart, Jr., M.D., Ph.D. Page 12 Curriculum Vitae Abstracts: 1. Earhart, RH, Wheeler, RH and Bull, FE. Pharmacokinetic Evidence for

Biotransformation of cis-dichlorodiammine Platinum (II) in Man. Clin Res 1977;35(3):269A

2. Wheeler, RH, Earhart, RH and Bull, FE. Bleomycin, Oncovin, Mitomycin-C ±

Methotrexate for Squamous Cell Carcinoma. Proc. ASCO 1979;20:348 3. Earhart, RH. Effect of Chloride Excretion on Nephrotoxicity Due to Cisplatin (CDDP).

Proc. AACR 1979;20:147 4. Earhart, RH, Martin, P, Pruitt, B and Rose, DP. Improvement in Cisplatin Therapeutic

Index by Increased Urinary Chloride Excretion. Fed Proc 1980;39(3):310 5. Earhart, RH, Stevens, R and Martin, P. Evidence for Renin-Independent Acute

Nephrotoxicity of Cisplatin (CDDP). Proc AACR 1980;21:287 6. Earhart, RH, Koeller, JM and Davis, HL. A Phase I Trial of PCNU (NSC-95466) on a 5-

Day Schedule. Proc ASCO 1980;21:356 7. Earhart, RH. Protection against Cisplatin Nephrotoxicity: Evidence for Two Forms of

Heavy Metal Nephropathy. NCI-EORTC Symposium on Nature, Prevention and Treatment of Clinical Toxicity of Anticancer Agents. Brussels, Belgium (Sept. 1980).

8. Earhart, RH, Stevens, R, Martin, PM and Tutsch, K. Pharmacokinetics and Metabolism

of 35S-thioproline (Norgamem) in the Dog. EORTC Symposium on New Approaches in Cancer Therapy. Madrid, Spain (October 1980).

9. Earhart, RH and Tutsch, KD. A Sensitive High Performance Liquid Chromatographic

Assay for ICRF-187 (NSC-169780) in Serum. Proc ASCO 1981;22:350 10. Leopold, WR, Batzinger, RP, Miller, JA, Miller, EC and Earhart, RH. Electrophilic,

Mutagenic, and Carcinogenic Properties of Antitumor Dichlorodiammine- and 1,2-diaminocyclohexane Platinum (II) Complexes. Proc AACR 1981;22:108

11. Earhart, RH, Koeller, JM and Davis, HL. Phase I Clinical Trial of the Glutamine

Antagonist DON (NSC 7365) on a 5-Day Schedule. Proc AACR 1981;22:190 12. Koeller, JM, Earhart, RH, Davis, TE, Borden, EC, Tormey, DC and Johnson, RO. Phase

I Clinical Trial of Acivicin (NSC-163501) by 72-Hour Infusion. Proc ASCO 1982;1:15 13. Earhart, RH, Tutsch, KD, Koeller, JM, Robins, HI and Tormey, DC. Pharmacokinetics of

ICRF-187 in Man. Proc AACR 1982;23:128 14. Witte, RS, Chang, AY-C, Tormey, DC, Earhart, RH, Borden, EC, Ramirez, G, Hogan, T

and Bryan, GT. Vindesine Sulfate: A Phase II Trial in Small Cell Bronchogenic Carcinoma. Proc ASCO 1982;1:143

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Robert H. Earhart, Jr., M.D., Ph.D. Page 13 Curriculum Vitae 15. Earhart, RH and Koeller, JM. Levonantradol vs. Prochlorperazine as Parenteral

Antiemetics in Cancer Patients Receiving Cisplatin Chemotherapy. Proc AACR 1983;24:163

16. Koeller, JM, Earhart, RH, Trump, DL, Tutsch, KD and Tormey, DC. Phase I Trial of

Carboplatin (NSC-241240) by Brief Intravenous Infusion. Proc AACR 1983;24:162 17. Tutsch, KD, Koeller, JM, Earhart, RH, Davis, TE, Trump, DL and Tormey, DC. Phase I

Trial and Pharmacokinetics of Concurrent Intravenous Misonidazole and Cyclophosphamide. Proc ASCO 1983;2:29

18. Kaplan, BH, Vogl, SE, Amato, D, Earhart, RH and Lerner, H. Single Agent

Chemotherapy of Advanced Head and Neck Cancer. Proc ASCO 1983;2:165 19. Earhart, RH, Kamen, BA, Tutsch, KD and Holcenberg, JC. Pharmacokinetics of (+)-1,2-

DI(3,5-Dioxopiperazine-1-yl)Propane (L-ICRF) in Children. Clin Pharm Therap 1984;35:238

20. Earhart, RH, Hamilton, RD, Henry, CS, Hanover, CK, Maile, MH, Agrawal, BL and Todd, WM. Phase I Trial, Pharmacokinetics and Interferon (IFN) Induction of an Oral Divided-Dose Schedule of 2-Amino-5-Bromo-6-Phenyl-4(3H)-Pyrimidinone (ABPP) in Cancer Patients. Proc AACR 1985;26:159

21. Earhart, RH, Hamilton, RD, Henry, CS, Hanover, CK, Maile, MH, Agrawal, BL and Todd,

WM. 2-Amino-5-Bromo-6-Phenyl-4(3H)-Pyrimidinone (ABPP): Phase I Trial of a Well-Tolerated Oral Interferon-Inducing Drug in Cancer Patients. Recent Advances in Chemotherapy, pp. 688-689 (1985).

22. Borden, E, Amato, D, Earhart, R and Chang, A. Phase II Evaluation of Diazonorleucine

(DON) and Aclacinomycin A (ACM-A) for Soft Tissue or Bone Sarcomas and Mesothelioma. Proc ASCO 1986;5:131

23. Earhart, RH, Hamilton, RD, Maile, MH, Spillers, CR, Hanover, CK, Stott, PB and Todd,

WM. Phase I Trial of Bropirimine: Toxicity, Antitumor Responses and Immunologic Pharamcodynamics of a Multiple-Dose Oral Regimen in Adult Solid Tumor Patients. Joint EORTC-NCI Annual Meeting, Oct. 1986. Invest New Drugs 1987;5(1):100

24. Earhart, RH, Muggia, FM, Falkson, G, Benson, AB III, Bennett, JM, and Schutt, AJ.

Activity of Acivicin in Colorectal Carcinoma. Proc AACR 1987;28:200 25. Adams, WJ, Brewer, JE, Hosley, JD, Earhart, RH, Kuhn, J, Weiss, G, and Brown, T.

Systemic Bioavailability and Pharmacokinetics of Orally Administered Menogaril. Proc AACR 1987;28:195

26. Brown, T, Weiss, G, Kuhn, J, Beougher, K, Harmon, G, Adams, W, Rodriguez, A,

Kasunic, D, Von Hoff, D, and Earhart, R. Orally Administered Menogaril: A Phase I Clinical and Pharmacologic Study. Proc ASCO 1987;6:36

27. Hamilton, RD, Renis, HE, Merritt, JA, Court, BA, Earhart, RH, Leach, MF, Gray, JE and

Kramer, GD. The Induction of 2',5'-Oligoadenylate Synthetase in Guinea Pigs and

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Robert H. Earhart, Jr., M.D., Ph.D. Page 14 Curriculum Vitae

Humans Treated Intravaginally with Bropirimine can be Detected in Small Punch Biopsies. Second Conference on Immunity to Cancer, Williamsburg, VA, November 9-11, 1987.

28. Earhart, RH. Menogaril - An Active Phase II Agent for Solid Tumors. Proc.

Chemotherapy Foundation Symp VIII, 18 November 1988 . 29. Bailey H, Williams, MH, McGovren, JP, and Earhart, RH. Prevention of Acivicin-Induced

Feline CNS Toxicity by Infusion of a Mixture of Four Large Neutral Amino Acids. Proc AACR 1989;30:533

30. Welch, D, Earhart, RH, Aeed, P, Howrey, R, Schissel, D, and Hendrix, M. Experimental

Metastatic Potential of Rat Mammary Tumor Cells in Modulated by Factors Secreted by Tumor Cells. Proc AACR 1989;30:89

31. Whitehead, RP, Earhart, RH, Goodman, P, MacDonald, JS, Pollock,T, and Ungerleider,

JS. A Phase II Study of Menogaril (NSC 269148) in Colorectal Carcinoma. Proc ASCO 1989;8:117

32. Adams, WJ, Hosley, JD, McGovren, JP, Smith, TC, and Earhart, RH. Interspecies

Comparison of Oral Bioavailability. PMA/FDA Co-sponsored Workshop on Use of Animals as Substitutes for Humans in Oral Bioavailability Studies, 29 June 1989.

33. Dodion, PF, Piccart, MJ, Bartholomeus, S, Domange, AM, and Earhart, RH. Phase II

Trials in Breast Cancer (BRCA) with the New Anthracycline Antibiotic Menogaril (MEN) Given Orally. Proc ECCO-5 1989;P-1009

34. Martino, S, Piccart, MJ, Dodion, PE, Chuang-Stein, C, Flaherty, L, Redman, B,

Valdivieso, M, English, PA and Earhart, RH. Phase II Study of Daily x 3 Oral Menogaril in Advanced Breast Cancer. Proc ASCO 1990;9:52

35. Spicer, D, Link, J, Figlin, R, Muggia, FM, Kasunic, DA, Maile, MH and Earhart, RH.

Phase II Study of Menogaril, Cyclophosphamide and 5-Fluorouracil (TCF) in Advanced Breast Cancer. Proc ASCO 1990;9:48

36. Fleming, GF, Ratain, MJ, O'Brien, S, Vogelzang, NJ, and Earhart, RH. Phase I Study of

Adozelesin by 24-hr infusion. Proc AACR 1992;33:265 37. Burris, H, Earhart, R, Kuhn, J, Schaffer, D, Campbell, L, Weiss, G, O'Rourke, T, Smith,

L, Kasunic, D, Padbury, G, and Van Hoff, D. A Phase I Clinical and Pharmacokinetic Trial of Adozelesin. Ann Oncol 1992;3:132

38. Ratain, MJ, Von Hoff, DD, Alberts, DS, Foster, BJ and Earhart, RH. Phase I Trial

Program for Adozelesin (U-73,975). Ann Oncol 1992;3:160 39. Burris, H, Earhart, RH, Kuhn, J, Shaffer, D, Smith, L, Weiss, G, Kasunic, D, Padbury, G,

Campbell, L, and Von Hoff, D. A Phase I Trial of Adozelesin, A Novel DNA Sequence-specific Alkylating Agent. Proc AACR 1992;33:520

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Robert H. Earhart, Jr., M.D., Ph.D. Page 15 Curriculum Vitae 40. Henrar, REC, Ratke, CC, Earhart, RH. Toxicology profile of carzelesin (U-80,244), a

prodrug cyclopropylpyrroloindolo (CPI) analogue. Proc AACR 1993;34:429 41. Sarosdy, MF, Lowe, BA, Schellhammer, PF, Lamm, DL, Graham, Jr, SD, Grossman, HB,

See, WA, Peabody, JO, Moon, TD, Flanigan, RC, Crawford, ED and Earhart, RH. Bropirimine immunotherapy of bladder CIS: Positive phase II results of an oral interferon inducer. Proc ASCO 1994;13:233

42. Sarosdy, MF, Lowe, BA, Schellhammer, PF, Lamm, DL, Graham, SD Jr, Grossman, HB,

See, WA, Peabody, JO, Moon, TD, Flanigan, RC, Crawford, ED, and Earhart, RH. Bropirimine Immunotherapy of Bladder CIS: Positive Phase II Results of an Oral Interferon Inducer. AUA 89th Annual Meeting 1994;13:304A

43. Schaaf, LJ, Vogelzang, NJ, Chambers, JH, Janisch, L, Earhart, RH, Gutknecht, GD,

Ratain, MJ. Effect of Food and Comparative Bioavailability of Orally Administered Bropirimine in Solid Tumor Patients. Proc ASCO 1995;14:462

44. Valero V, Burris HA III, Jones SE, Booser DJ, Ravdin P, Mennel R, Schottstaedt M,

Esparaza-Guerra L, Kwiecinski C, Earhart R, Von Hoff DD, and Hortobagyi GN. Multicenter Pilot Study of Taxotere in Taxol-Resistant Metastatic Breast Cancer. Proc ASCO 1996;15:107

45. Valero V, Burris HA III, Earhart R, Von Hoff DD, and Hortobagyi GN. A Phase II Study of

Docetaxel in Patients with Paclitaxel-Resistant Metastatic Breast Cancer. Proc ESMO 1998.

46. Singer J, Kirkhart B, Frank K, Earhart R. Safety Experience with Trisenox® (Arsenic

Trioxide) Injection. Proc ASH 2003, abstract 5767. 47. Oliva C, Kirkhart B, Maxon MS, Earhart, R. Safety Experience with Trisenox® (Arsenic

Trioxide) Injection. Proc EHA 2004, abstract 522. 48. Holman J, Kirkhart B, Maxon MS, Oliva C, Earhart R. Safety Experience with Trisenox®

(Arsenic Trioxide) Injection. Proc ASH 2004, abstract 4521.

49. Earhart RH, Cheporov SV, Gladkov OA, Biakhov MY, Baker GS, Breitz HB. Preliminary results of a Phase II study of picoplatin in combination with 5-fluorouracil and leucovorin (FOLPI) as a potential neuropathy-sparing first-line therapy for colorectal cancer (CRC). 20th NCI-EORTC-AACR Symposium 2008, abstract 210.

50. DeJager R, Roman L, Lopatkin N, Karlov P, Breitz HB, Earhart RH. Results of a Phase

II study of picoplatin with docetaxel and prednisone in chemotherapy-naïve patients with metastatic hormone refractory prostate cancer. 20th NCI-EORTC-AACR Symposium 2008, abstract 211.

51. Earhart RH, Cheporov SV, Gladkov OA, Biakhov MY, Baker GS, Breitz HB.

Randomized Phase 2 study of picoplatin in combination with 5-fluorouracil and leucovorin (FOLPI) as a neuropathy-sparing alternative to mFOLFOX-6 as first-line therapy for colorectal cancer (CRC). Proc ASCO GI Symposium, 2009.

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Robert H. Earhart, Jr., M.D., Ph.D. Page 16 Curriculum Vitae 52. Earhart R, Roman L, Lopatkin N, Karlov P, Breitz H, DeJager R. Results of a Phase II

study of picoplatin with docetaxel and prednisone in chemotherapy-naïve patients with metastatic hormone refractory prostate cancer (HRPC). Proc ASCO GU Symposium, 2009.

53. Earhart RH, Gladkov OA, Cheporov SV, Biakhov MY, Manikhas G, Berdov B, Tjulandin

S, Breitz HB, DeJager RL. A Phase 1 study of picoplatin in combination with 5-fluorouracil and leucovorin (FOLPI) for colorectal cancer (CRC): Comparison of two picoplatin schedules. Proc AACR 2009.

54. Phillips A, Saleh M, Yee L, Sharma S, Houston S, Karlin D, Breitz H, Earhart R. A

Phase 1 randomized crossover oral picoplatin bioavailability pharmacokinetics and pharmacodynamics study. Proc AACR 2009.

55. Earhart RH, Cheporov SV, Gladkov OA, Biakhov MY, Breitz HB, De Jager RL, and the

FOLPI Study Group. Randomized Phase 2 study of picoplatin in combination with 5-fluorouracil and leucovorin (FOLPI) as a neuropathy-sparing alternative to mFOLFOX-6 as first-line therapy for colorectal cancer (CRC). Proc ASCO 2009.

56. De Jager RL, Roman LD, Lopatkin NA, Karlov PA, Breitz HB, Earhart RH. Results of a

Phase II study of picoplatin with docetaxel and prednisone in first-line treatment of castration-resistant prostate cancer (CRPC). Proc ASCO 2009.

57. De Jager RL, Cheporov SV, Gladkov OA, Biakhov MY, Breitz HB, Earhart RH, and the

FOLPI Study Group. Randomized Phase 2 study of Picoplatin in Combination with 5-fluorouracil and Leucovorin (FOLPI) as a Neuropathy-sparing Alternative to mFOLFOX-6 as First-line Therapy for Colorectal Cancer (CRC). Proc AACR-NCI-EORTC, 2009.

58. Earhart RH, Rosen L, Mendelson D, Plaxe S, Gold P, Yee L, Mansoor S, Verschraegen

C, Phillips A, Houston S, De Jager RL. QTc Study of Picoplatin with Emphasis on Pharmacodynamics of Cardiac Repolarization. Proc AACR-NCI-EORTC, 2009.

59. Earhart RH, Cheporov SV, Gladkov OA, Biakhov MY, Breitz HB, De Jager RL, and the

FOLPI Study Group. FOLPI (picoplatin/5-fluorouracil/leucovorin) versus modified FOLFOX-6 as first-line therapy for colorectal cancer (CRC). Proc ASCO GI Symp, 2010.

60. De Jager RL, Roman LD, Lopatkin NA, Karlov PA, Breitz HB, Earhart RH. Phase II

study of picoplatin with docetaxel and prednisone in first-line treatment of castration resistant prostate cancer (CRPC). Proc ASCO GU Symp, 2010.

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