A Safety and Dose-finding Study of JNJ-26483327, a Drug in Development for Cancer, for Patients With Advanced and/or Refractory Solid Malignancies.

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess JNJ-26483327 (a drug in development for cancer) for the safety of the drug in patients with advanced solid tumors that have not responded or are no longer responding to available therapies. The absorption, breakdown and elimination of the drug will also be studied.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Janssen Pharmaceutica N.V., Belgium

Criteria

Inclusion Criteria:

• Confirmed diagnosis of solid malignancy that is advanced or refractory and progressing and for which standard treatments do not exist or are no longer effective

• radiological assessment of disease within 4 weeks of first study drug administration

• overall health status as determined by the Eastern Cooperative Oncology Group (ECOG) < = 2

• life expectancy > 3 months

• adequate gastrointestinal absorption and ability to swallow

• left ventricular ejection fraction (LVEF) > 50% and protocol-defined criteria for laboratory tests.

Exclusion Criteria:

• Cancer has spread to the central nervous system

• chemotherapy, radiotherapy, immunotherapy within 4 weeks before study drug administration or incomplete recovery from preceding surgery or toxicity of prior anticancer therapy (excluding peripheral neuropathy and alopecia)

• history of uncontrolled heart disease as defined in the protocol

• history of pulmonary fibrosis

• acute infection requiring systemic therapy.