drugset
drugset / Trial / NCT00954512

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

NCT00954512 ↗

Phase 1/2 Terminated 15 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-09-25
Primary completion
2011-06-07
Completion
2011-06-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Robatumumab Monoclonal antibody 10 mg/kg Intravenous
Subject Robatumumab Monoclonal antibody 15 mg/kg Intravenous
Subject Robatumumab Monoclonal antibody 20 mg/kg Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Background Cisplatin Other / unclassified 60 mg/m2 Intravenous
Background Epirubicin Small molecule 50 mg/m2 Intravenous
Background Erlotinib Small molecule 100 mg Oral
Background Everolimus Small molecule 10 mg Oral
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Paclitaxel Small molecule 225 mg/m2 Intravenous
Background Trastuzumab Monoclonal antibody 4 mg/kg Intravenous
Background fluorouracil Small molecule 200 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

neoplasm