A Safety and Dose-finding Study of JNJ-38877605 in Patients With Advanced or Refractory Solid Tumors.
|ClinicalTrials.gov Identifier: NCT00651365|
Recruitment Status : Terminated (Early termination due to increase in serum creatinine levels and minimal PD activity.)
First Posted : April 2, 2008
Last Update Posted : March 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: JNJ-38877605||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of the Selective Met Inhibitor JNJ-38877605 in Subjects With Advanced or Refractory Solid Tumors|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
- Determine the safety and tolerability of JNJ-38877605 by assessment of the adverse event profile (throughout the study), dose-limiting toxicity (Cycle 1), and the maximum tolerated dose.
- Determine the pharmacokinetic profile of JNJ-38877605 and its metabolite, JNJ-40434654 and to investigate the potential impact of food on the PK profile (Cycle 1). Explore the pharmacodynamic effects and measure anti-tumor activity of JNJ-38877605.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651365
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|