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.
A Phase I Study to Evaluate the Safety and Pharmacokinetics of R306465 in Subjects With Advanced Solid Malignancies
1 other identifier
interventional
15
0 countries
N/A
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, breakdown and elimination of the drug will be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2005
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
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedApril 27, 2010
April 1, 2010
April 24, 2008
April 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the safety and maximum tolerated dose of R306465 when given as a daily oral dose during 3 weeks followed by a 1 week recovery period. Study the absorption, break down and elimination of R306465 following oral administration.
Secondary Outcomes (1)
Investigate the effect of food on oral administration of R306465. Evaluate the antitumor activity of R306465 in patients with measurable cancer.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
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
April 24, 2008
First Posted
May 13, 2008
Study Start
September 1, 2005
Study Completion
October 1, 2006
Last Updated
April 27, 2010
Record last verified: 2010-04