Phase I (PH I) Mad Refractory Solid Tumor Study
NCT00099606 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2011-04-19
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, effect of food, and continue exploratory research of BMS-354825 in patients with solid tumors not responding to standard treatment, or for which no effective standard treatment exists.
Conditions
- Neoplasms
Interventions
- DRUG
-
Tablets, Oral, Dose Finding Study - Range was 35 mg BID, 5 days on/2 days off - 120 mg BID Continuous Daily Dosing, Once daily, Patients remained on study until treatment discontinuation due to unacceptable toxicity, disease progression or death.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-07-31
- Primary Completion
- 2007-07-31
- Completion
- 2007-07-31
Countries
- United States
- United Kingdom
Study Locations
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