Spots Global Cancer Trial Database for Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors
Official Title: A Phase I Study of ARQ 197 in Combination With IV Topotecan in Advanced Solid Tumors With an Expansion Cohort in Small Cell Lung Cancer
Study ID: NCT01654965
Conditions
Study Description
Brief Summary: This phase I trial studies the side effects and best dose of tivantinib and topotecan hydrochloride in treating patients with advanced or metastatic solid tumors. Tivantinib and topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To establish the recommended phase 2 dose (RP2D) for the combination of ARQ 197 (tivantinib) and intravenous (IV) topotecan (topotecan hydrochloride). II. To describe the toxicities of ARQ 197 and IV topotecan at each dose studied. III. To characterize the pharmacokinetic behavior of ARQ 197 given concurrent use of IV topotecan. IV. To document all clinical responses to ARQ 197 with IV topotecan. OUTLINE: This is a dose-escalation study of tivantinib and topotecan hydrochloride. Patients receive tivantinib orally (PO) twice daily (BID) on days 1-21, topotecan hydrochloride IV over 30 minutes on days 1-5, and pegfilgrastim subcutaneously (SC) on day 6. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
City of Hope South Pasadena, South Pasadena, California, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Contact Details
Name: Barbara Gitlitz
Affiliation: City of Hope Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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