A Phase 1 Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of the Selective Met Inhibitor, JNJ 38877605 in Subjects With Advanced or Refractory Solid Tumors.

Completed

• Conditions: Advanced or Refractory Solid Tumors; available therapies; no longer likely to benefit from approved; 10027655

• Registration Number: NL-OMON31546
• Lead Sponsor: Johnson & Johnson Pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

histologically or cytologically confirmed advanced or refractory solid
tumor and no longer eligible for approved, available standard therapies

Exclusion Criteria

known brain metastases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the safety and tolerability of JNJ-38877605 (adverse event<br /><br>profile, dose-limiting<br /><br>toxicity and the maximum tolerated dose).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the pharmacokinetic (PK) profile of JNJ-38877605 and its<br /><br>N-desmethyl metabolite,<br /><br>JNJ-40434654 and investigate the potential impact of food on the PK profile.<br /><br>To explore pharmacodynamic effects of JNJ-38877605.<br /><br>To measure antitumor activity in response to administration of JNJ-38877605.</p><br>