A Safety and Dose-finding Study of JNJ-38877605 in Patients With Advanced or Refractory Solid Tumors.
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|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|
|Experimental: 001||Drug: JNJ-38877605|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|