NCT01332604

GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors

A Phase Ib, Open Label, Dose Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors.

Conditions

• Solid Cancers

Interventions

Type	Name	Description
DRUG	GDC-0980	Oral escalating dose
DRUG	bevacizumab	Intravenous repeating dose
DRUG	capecitabine	Oral repeating dose
DRUG	mFOLFOX6	Intravenous repeating dose

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2011-04-11
• Last updated: 2016-11-02

Locations

4 sites across 2 countries: United States, Spain