drugset / Trial / NCT00958724

Study Evaluating Neratinib In Combination With Vinorelbine In Subjects With Advanced Or Metastatic Solid Tumors

NCT00958724

Phase 1 Completed 6 enrolled Puma Biotechnology, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The purposes of this study are to evaluate the safety and tolerability of neratinib in combination with vinorelbine at the maximum tolerated dose (MTD) determined in a previous study, or to determine a lower MTD of the two drugs, as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors in Japanese patients.

Timeline

Start
2009-07
Primary completion
2010-04
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Neratinib Small molecule 240 mg Oral
Subject Vinorelbine Small molecule 25 mg/m2 Intravenous

Indications