Clinical trial · Interventional
A Safety and Dose-finding Study of JNJ-38877605 in Patients With Advanced or Refractory Solid Tumors.
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
NCT00651365CI-TRIAL-00009685terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early termination due to increase in serum creatinine levels and minimal PD activity.
Summary
Brief summary (as posted)
This purpose of the study is to determine what dose of JNJ-38877605 is safe and if JNJ-38877605 has any effect in patients with advanced or refractory solid tumors for which there are not alternative therapies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-38877605 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 001
- interventionNames
- Drug: JNJ-38877605
Primary outcomes (1)
- measure
- 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.
Secondary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed advanced or refractory solid tumor no longer eligible for approved therapies * Eastern Cooperative Oncology Group performance status test score of \<=2 * Must meet protocol lab criteria which will include lab assessment of adequate bone marrow function, liver function, and renal function. Exclusion Criteria: * Any medical condition that requires wound healing during the study (for example chronic leg ulcers, gastric ulcer disease, or expected major surgery) * Major surgery within 3 weeks before enrollment * Decreased or deficient coagulability of blood (for example genetic defects such as protein Z deficiency) or compliance problems in subjects required to take anticoagulants (e.g., coumarin derivates, acetylsalicylic acid) which could result in decreased or deficient coagulability * Chemotherapy (for nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy, or any other investigational agent within 3 weeks before study drug administration * antibody therapy within 3 months before administration of JNJ-38877605 * brain metastases * History of uncontrolled heart disease within 12 months before enrollment or any protocol-defined cardiovascular abnormalities * Patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
References
Publications (0)
Data not yet available
No reference posted for this study.