NCT02386826

INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme

Phase Ib Study Evaluating the c-Met Inhibitor INC280 in Combination With Bevacizumab in Patients With Glioblastoma Multiforme (GBM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the combination of two agents, INC280 and bevacizumab, is safe and effective when administered to patients with Glioblastoma Multiforme (GBM) who have progressed after receiving prior therapy or who have unresectable GBM.

Detailed description

Despite recent advances, glioblastoma multiforme (GBM) remains an incurable malignancy with a short expected survival. c-MET signalling promotes invasive growth and has been described in various cancers. INC280 is a highly potent and selective c-MET inhibitor which also penetrates the blood-brain barrier. In this open-label, multicenter Phase 1b study, investigators determined the optimal dose of the INC280/bevacizumab combination to administer to patients. Enrollment has now expanded in order to treat 3 cohorts of GBM patients: those who progressed after ≥ first-line standard therapy, those who progressed after ≥ second-line therapy with INC280/bevacizumab, and those with unresectable GBM.

Conditions

• Glioblastoma Multiforme
• Gliosarcoma
• Colorectal Cancer
• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	INC280	Dose Escalation: INC280 by mouth (PO) twice daily for 28 days according to the following schedule until the maximum tolerated dose (MTD) is determined: Dose Level 1 (starting dose): 200 mg (divided dose of 100 mg twice per day) Dose Level 2: 400 mg (divided dose of 200 mg twice per day) Dose Level 3: 800 mg (divided dose of 400 mg twice per day) Dose Expansion: INC280 PO twice daily at the MTD determined in the dose escalation phase
BIOLOGICAL	bevacizumab	bevacizumab: 10 mg/kg IV every 2 weeks. Patients with unresectable GBM will be given 15 mg/kg IV every 4 weeks.

Timeline

• Start date: 2015-09-22
• Primary completion: 2021-07-31
• Completion: 2023-08-23
• First posted: 2015-03-12
• Last updated: 2023-09-21

Locations

5 sites across 1 country: United States