Pharmacokinetics Clinical Trial
Official title:
An Open-label, Phase I Study to Determine the Safety and Pharmacokinetics of JNJ-26483327, a Multi-targeted Kinase Inhibitor, Administered to Subjects With Advanced Stage and/or Refractory Solid Malignancies
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | July 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Janssen Pharmaceutica N.V., Belgium |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the safety (effects on the body) and the maximum tolerated dose of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 taken by patients as an oral capsule is absorbed, broken down and eliminated. | |||
Secondary | Assess the anti-cancer activity of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 works in patients with cancer. |
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