Status:
COMPLETED
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.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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, breakd...
Detailed Description
R306465, a histone deacetylase (HDAC) inhibitor, is a new drug in development for cancer. In this study, the safety (the effect on the body) of R306465 in patients with advanced cancer will be studied...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00677001
Start Date
September 1 2005
End Date
October 1 2006
Last Update
April 27 2010
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