A Safety and Dose-finding Study of JNJ-38877605 in Patients With Advanced or Refractory Solid Tumors.

NCT00651365 | Terminated Phase 1 DMC

• 1 other identifier: CR014644
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Neoplasms

Keywords

Advanced solid tumors; Refractory solid tumor; Antineoplastic protocol; Drug therapy; Pharmacokinetics; Met inhibitor

Outcome Measures

Primary Outcomes (1)

• 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)

• 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.

Study Arms (1)

001

EXPERIMENTAL

Drug: JNJ-38877605

Interventions

JNJ-38877605 DRUG

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho Biotech, Inc.: collaborator

MeSH Terms

Conditions

Neoplasms

Interventions

JNJ38877605

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 8, 2013

Record last verified: 2013-03