Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)

• Status: Terminated
• Trial end date: 2011-06-07

Summary

This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label study designed to evaluate the safety and tolerability of robatumumab (SCH 717454, MK-7454) in combination with standard treatment in participants with advanced solid tumors to be conducted in conformance with Good Clinical Practices.

Six different treatment regimens will be investigated in combination with robatumumab.

The study will be divided into two parts. Part 1 will consist of initial safety evaluation and dose-finding of robatumumab in combination with each treatment regimen. Part 2 will consist of an expansion of each robatumumab regimen at a newly established dose level, to better define safety, tolerability, and initial efficacy in specific target populations.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Carboplatin; Cetuximab; Cisplatin; Epirubicin; Erlotinib Hydrochloride; Everolimus; Folic Acid; Gemcitabine; Irinotecan; Leucovorin; Levoleucovorin; Paclitaxel; Sirolimus; Trastuzumab