A Research Study to Evaluate the Safety of R306465, a Drug in Development for Cancer and to Study the Absorption, Break Down and Elimination in Patients With Advanced Solid Malignancies.

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety of R306465 (a drug in development for cancer) in patients with advanced cancer on the maximum dose that can be tolerated. Also, the absorption, breakdown and elimination of the drug will be studied.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Janssen-Cilag Ltd.
• Treatments: R 306465

Criteria

Inclusion Criteria:

• Confirmed solid malignancy that is metastatic or unresectable, and for which standard curative or palliative measures does not exist or are no longer effective

• Performance status (based on the Eastern Cooperative Oncology Group assessments) of <= 2

• Life expectancy > 3 months

• Adequate gastrointestinal absorption status

• Must meet protocol-defined criteria for lab assessments and adequate bone marrow, liver, and kidney function.

Exclusion Criteria:

• Known central nervous system metastases

• Chemotherapy, radiotherapy, immunotherapy within 4 weeks before study drug administration or incomplete recovery from preceding surgery

• Previous participation in a clinical study with histone deacetylase (HDAC) inhibitor or another investigational anticancer agent within 4 weeks of dosing with R306465

• Patient has signs and symptoms of acute infection requiring systemic therapy

• Patient is not recovered from reversible toxicity of prior anticancer therapy.