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Phase I Pharmacokinetic Study of Belinostat for Solid Tumors and Lymphomas in Patients with Varying Degrees of Hepatic Dysfunction

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Phase I Pharmacokinetic Study of Belinostat for Solid Tumors and Lymphomas in Patients with Varying Degrees of Hepatic Dysfunction CTEP #8846 Clinical Center #11-C-0060 Phase I Pharmacokinetic Study of Belinostat for Solid Tumors and Lymphomas in Patients with Varying Degrees of Hepatic Dysfunction Abbreviated Title: PhI Belinostat ODWG Coordinating Center: Developmental Therapeutics Clinic (DTC) National Cancer Institute 10 Center Drive, 12N226 Bethesda, MD 20892 Principal Investigator: Naoko Takebe, MD, PhDA-E, DTC Bldg 31 Room 3A44 Bethesda, MD 20892 Phone: (240) 781-3398; Fax: (240) 541-4515 [email protected] NIH Co-Investigators: James H. Doroshow, MDA-E, DCTD Alice P. Chen, MDA-E, DCTD Howard Streicher, MDA-E, CTEP/DCTD Geraldine O’Sullivan Coyne, MDA-E, DCTD Non-NCI Co-investigators Lamin Juwara, CRNPA,B,E, Leidos Biomed/FNLCR Participating Centers: NCI Organ Dysfunction Working Group (ODWG): Albert Einstein College of Medicine University of California Davis Cancer Center Emory University University of Southern California/Norris Karmanos Cancer Institute Comprehensive Cancer Center City of Hope Comprehensive Cancer Center Referral Contact: Nancy Moore, RNA,B,E Bldg 10/RM 8D53 National Cancer Institute Phone: (240) 760-6045; Fax: (301) 451-5625 [email protected] Roles: Aobtains information by intervening or interacting with living individuals for research purposes; Bobtains identifiable private information about living individuals; Cobtains the voluntary informed consent of individuals to be subjects; Dmakes decisions about subject eligibility; Estudies, interprets, or analyzes identifiable private information or data/specimens for research purposes 1 CTEP #8846 Clinical Center #11-C-0060 CoH Pharmacy Contact: Timothy Synold, Pharm D FWA#: 00000692 (626) 256-4673 x 62110 Fax: (626) 471-9376 PI: Vincent Chung, MD, FACP [email protected] (626) 471-9200 Fax: (626) 301-8233 Cecilia Lau, Clinical Pharmacist [email protected] (626) 256-4673 x 64165 Fax: (626) 301-5237 PI: Edward Newman, Ph.D. [email protected] City of Hope Comprehensive Cancer Center 1500 East Duarte Road Regulatory Coordinator: Duarte, CA. 91010 Stella Chen Khoo, MBA (626) 256-4673 x 62566 Project Administrator Fax: (626) 301-8654 Data Coordinating Center [email protected] California Cancer Consortium Phone: (626) 256-4673 ext. 60094 IRB Contact: Amanda Hammond Fax: (626) 256-8654 IRB of Record Name: City of Hope Natl Med Pager: (626) 423-5365 Ctr & the Beckman Rsch Inst IRB#1 [email protected] and [email protected] IRB IORG#: IORG0000042 1500 E. Duarte Rd. Duarte, CA 91010 Phone: (626) 256-4673 X 89084 Fax: (626) 245-8695 [email protected] USC IRB Contact: Sandy Jean FWA#: 00005906 IRB of Record Name: University of Southern California Health Sciences Institutional Review PI: Heinz-Josef Lenz, M.D. Board USC/Norris Comprehensive Cancer Center IRB IORG #: IRB00000484 1441 Eastlake Avenue LAC+USC Medical Center Los Angeles, CA 90033 General Hospital Suite 4700 Phone: 323-865-3955, Fax: 323-865-0061 1200 North State St. [email protected] Los Angeles, CA 90033 Phone Number: (323) 276-2231 PK Coordinator: Isabell Nungaray [email protected] [email protected] Shipping Address: USC/Norris Comprehensive Cancer Center 1441 Eastlake Ave., Room 7408 Los Angeles, CA 90033 2 CTEP #8846 Clinical Center #11-C-0060 UCD Clinical Research Coordinator: FWA#: 00004557 Corinne Turrell, CCRP UC Davis Comprehensive Cancer Center PI: David Gandara, MD 4501 X Street, Suite 1009 UC Davis Cancer Center Sacramento, CA 95817 45021 X Street, Suite 3016 Phone: 916-734-3089, Fax: 916-734-4177 Sacramento, CA 95817 [email protected] Phone: 916-734-3772, Fax: 916-734-7946 [email protected] IRB Contact: Cynthia Gates, JD, RN, CIP Director of IRB Administration PK Coordinator: Leslie Snyder-Solis, MS IRB of Record Name: UC Davis Office of Research, UC Davis Cancer Center IRB Administration Clinical Trials Support Unit IRB IORG #: 0000251 4501 X Street Suite 1009 2921 Stockton Blvd., Suite 1400, Room 1429 Sacramento, CA 95817 Sacramento, CA 95817 Phone: 916-734-6447, Fax: 916-734-4177 Phone Number: (916) 703-9154 [email protected] [email protected] NYC PK Coordinator: Mohammed Ghalib FWA#: 00000140 [email protected] Shipping Address: PI: Sanjay Goel, M.D., M.S. 1695 Eastchester Rd Albert Einstein College of Medicine Oncology 1st FL/AECOM Montefiore Medical Center Bronx, NY 10461 1825 Eastchester Road Phone: 718-405-8515 Bronx, NY 10461 Ph: 718-904-2488, Fax: 718-904-2830 IRB Contact: David Wallach [email protected] IRB of Record Name: Albert Einstein College of Medicine Institutional Review Board IRB IORG #:IRB00000081; IORG0000058 1300 Morris Park Avenue, Bronx, NY 10461 Phone: 718-430-2237 [email protected] 3 CTEP #8846 Clinical Center #11-C-0060 WSU FWA#:00002460 Regulatory Coordinator: Rachelle Zeleny PI: Ulka Vaishampayan, MD Karmanos Cancer Institute Wayne State University/Karmanos Cancer 87E. Canfield MM05P1 Institute Detroit, MI 48201 4HWCRC, 4100 John R HW04HO Phone: 313-576-9811; Fax: 313-576-9684 Detroit, MI 48201 [email protected] Phone: 313-576-8718, Fax: 313-576-8487 [email protected] IRB Contact: Rozelle Copeland IRB of Record Name: Wayne State University IRB PK Coordinator: Nikita Patel, MSc IRB IORG #:IRB00006856 Karmanos Cancer Institute (for the Phase I IRB at WSU) 87 E. Canfield MM05P1 Address: 87 E. Canfield, 2nd Floor Detroit, MI 48201 Detroit, MI 48201 Phone: 313-576-9723; Fax: 313-576-9684 Phone: (313) 577-1628 [email protected] [email protected] EMY PK Coordinator: Rijalda Deovic FWA#: 00005792 Emory University School of Medicine [email protected] PI: Bassel F. El-Rayes, MD 1365-C Clifton Road NE Emory University School of Medicine Suite C3012-C Building C, Room 2080 Atlanta, GA 30322 Atlanta, GA 30322 Phone:404-778-5849 Phone: 404-778-3882, Fax: 404-778-5676 [email protected] Eligibility Coordinator: Meredith Renfroe, CCRP Co-PI: Donald Harvey, PharmD Emory University Winship Cancer Institute Emory University School of Medicine 1365-C Clifton Road NE Building C, Room CPL017B Suite C3012-B Atlanta, GA 30322 Atlanta, GA 30322 Phone: 404-778-4381, Fax: 404-778-7720 Phone: 404-778-1802 [email protected] [email protected] IRB Contact: Rebecca Rousselle, BA, CIP IRB of Record Name: Emory University IRB IRB IORG #: #0000267 Address: 1599 Clifton Road NE, 5th Floor Atlanta, GA 30322 Phone Number: 404-712-0720 [email protected] 4 CTEP #8846 Clinical Center #11-C-0060 Statistician: Larry Rubinstein, PhDE Biometric Research Branch, NCI 9609 Medical Center Drive Rockville, MD 20850 Phone: (240) 276 6026 [email protected] NCI-Supplied Agent: Belinostat (NSC 726630) IND Number: 72990 CTEP Drug Monitors: Richard Piekarz, MD, PhD S. Percy Ivy, MD Protocol Version Date: October 25, 2018 5 CTEP #8846 Clinical Center #11-C-0060 PRÉCIS Background: Belinostat is a histone deacetylase (HDAC) inhibitor. HDACs are frequently deregulated in cancer cells, leading to an increase in deacetylation and the silencing of genes that normally control cell cycle arrest and apoptosis. Belinostat has growth inhibitory activity in several malignancies in vitro and in vivo, both as a single agent and in combination with chemotherapeutic agents. Several Phase I and II clinical trials have been conducted to date in patients with solid tumor and hematologic malignancies; belinostat has been generally well tolerated. Belinostat is metabolized in the liver and therefore, the safety and dosing of belinostat needs to be established in patients with varying degrees of hepatic dysfunction. Objectives: Establish the safety and tolerability of belinostat given on days 1–5 of 21-day cycles to patients with varying degrees of liver dysfunction. Define the maximum tolerated dose (MTD) and recommended dose of belinostat given on days 1–5 of 21-day cycles to patients with varying degrees of liver dysfunction. Evaluate the pharmacokinetics (PK) of one dose of belinostat (400 mg/m2) in patients with varying degrees of liver dysfunction Obtain preliminary evidence of anti-tumor activity at tolerable doses of belinostat in patients with varying degrees of liver dysfunction. Correlate observed toxicities with PK of belinostat in patients with varying degrees of liver dysfunction. Measure direct versus indirect bilirubin levels and correlate these with observed toxicities and PK. Eligibility: Adults with solid tumors or lymphomas whose disease has progressed after standard therapy or who have no acceptable standard treatment options. Patients with normal and varying degrees of hepatic dysfunction (mild, moderate, and severe) are eligible. Study Design: Patients will be divided into 4 cohorts based on their level of liver dysfunction. Belinostat will be administered IV over 30 minutes. On day -7 (Cycle 1 only), all patients will receive a single dose of 400 mg/m2 belinostat. On days 1–5 of each cycle, patients will receive belinostat at a dose dependent on the level of hepatic dysfunction (see below). The total length of Cycle 1 will be 28 days; all other cycles will be 21 days. No more than 12 patients with normal hepatic function will be accrued. 6 CTEP #8846 Clinical Center #11-C-0060 SCHEMA Cycle 1 Cycle 2 and beyond (total duration 28 days) (total duration 21 days) D1 D5 D21 B B B PK sampling D1 D5 D21 D -7 B = Belinostat, administered IV over 30 minutes. On Day -7 (Cycle 1 only), all patients will receive a single dose of 400 mg/m2 belinostat. Starting on Day 1, patients will receive the assigned dose of belinostat, according to the dose escalation scheme, for Days 1–5 of each cycle. Blood samples for correlative PK studies will be collected from all patients on Cycle
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