NCT00535522CompletedPhase 1
A Multicenter, Open-Label, Noncomparative Phase I Clinical and Pharmacokinetic Study of Oral TAK-285 in Patients With Advanced Cancer
Millennium Pharmaceuticals, Inc.3 sites in 1 country56 target enrollmentStarted: August 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 56
- Locations
- 3
- Primary Endpoint
- Safety profile, including dose-limiting toxicities, maximum tolerated dose, recommended Phase II dose; and the pharmacokinetic profile.
Study Overview
Brief Summary
The purpose of this study is to determine the safety and pharmacokinetics of TAK-285 in patients with advanced cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
TAK-285
Experimental
Intervention: TAK-285 Dose Escalation Cohorts (Drug)
TAK-285
Experimental
Intervention: TAK-285 Recommended Phase 2 Dosing Cohort (Drug)
Outcomes
Primary Outcomes
Safety profile, including dose-limiting toxicities, maximum tolerated dose, recommended Phase II dose; and the pharmacokinetic profile.
Time Frame: Duration of study
Secondary Outcomes
- Objective disease response by modified Response Evaluation Criteria in Solid Tumors.(Duration of study)
Investigators
Study Sites (3)
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