A Safety and Dose-finding Study of JNJ-26483327, a Drug in Development for Cancer, for Patients With Advanced and/or Refractory Solid Malignancies.
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
1 other identifier
interventional
19
0 countries
N/A
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 responding to available therapies. The absorption, breakdown and elimination of the drug will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 8, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedApril 26, 2010
April 1, 2010
May 8, 2008
April 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Assess the anti-cancer activity of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 works in patients with cancer.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 8, 2008
First Posted
May 13, 2008
Study Start
August 1, 2006
Study Completion
July 1, 2008
Last Updated
April 26, 2010
Record last verified: 2010-04