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.

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. - N/A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31546

Enrollment

Registered

2007-12-11

Start date

2008-05-14

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Refractory Solid Tumors available therapies no longer likely to benefit from approved

Interventions

NVT

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: known brain metastases

Design outcomes

Primary

Measure	Time frame
To determine the safety and tolerability of JNJ-38877605 (adverse event profile, dose-limiting toxicity and the maximum tolerated dose).	—

Secondary

Measure	Time frame
To determine the pharmacokinetic (PK) profile of JNJ-38877605 and its N-desmethyl metabolite, JNJ-40434654 and investigate the potential impact of food on the PK profile. To explore pharmacodynamic effects of JNJ-38877605. To measure antitumor activity in response to administration of JNJ-38877605.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)