Status:
COMPLETED
A Safety and Dose-finding Study of JNJ-26483327, a Drug in Development for Cancer, for Patients With Advanced and/or Refractory Solid Malignancies.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Protein Kinase Inhibitors
Antineoplastic Protocols
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 respon...
Detailed Description
JNJ-26483327, a multi-targeted reversible kinase inhibitor, is a new drug in development for treatment of cancer. This study will test the safety (the effect on the body) of JNJ-26483327 and the highe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00676299
Start Date
August 1 2006
End Date
July 1 2008
Last Update
April 26 2010
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