NCT01688973

Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery

Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well tivantinib with or without erlotinib hydrochloride works in treating patients with metastatic or locally advanced kidney cancer that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To assess the response rate (confirmed complete and partial response) of patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 (tivantinib) or ARQ 197 combined with erlotinib (erlotinib hydrochloride). SECONDARY OBJECTIVES: I. To assess the progression free survival (PFS) of patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 or ARQ 197 combined with erlotinib. II. To assess the safety and tolerability of ARQ 197 therapy and ARQ 197 combined with erlotinib. III. To descriptively assess the role of prior treatment on outcome. TERTIARY OBJECTIVES: I. To bank tissue specimens for future use and once funding is obtained to evaluate the expression of tissue correlative biomarkers such as hepatocyte growth factor receptor (c-MET) and epidermal growth factor receptor (EGFR), and to perform exploratory correlation with clinical outcomes. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28. ARM II: Patients receive tivantinib PO BID and erlotinib hydrochloride PO once daily (QD) on days 1-28. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for up to 2 years.

Conditions

• Recurrent Renal Cell Carcinoma
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer
• Type 1 Papillary Renal Cell Carcinoma
• Type 2 Papillary Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Erlotinib Hydrochloride	150 mg (1 tablet) by mouth on days 1-28, once daily, until disease progression
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Tivantinib	360 mg (3 tablets) by mouth, Twice daily (720 mg total daily dose) on days 1-28, until disease progression

Timeline

• Start date: 2012-08-20
• Primary completion: 2017-04-30
• Completion: 2017-04-30
• First posted: 2012-09-20
• Last updated: 2019-01-03
• Results posted: 2019-01-03

Locations

214 sites across 1 country: United States