NCT01654965

Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pegfilgrastim	Given SC
OTHER	Pharmacological Study	Correlative studies
DRUG	Tivantinib	Given PO
DRUG	Topotecan Hydrochloride	Given IV

Timeline

• Start date: 2012-07-24
• Primary completion: 2018-03-29
• Completion: 2018-03-29
• First posted: 2012-08-01
• Last updated: 2018-04-03

Locations

7 sites across 1 country: United States