Trials / Terminated
TerminatedNCT00162214
Study of Dasatinib in Patients With Advanced Solid Tumors
Phase I Study to Evaluate the Effect of Ketoconazole on the Pharmacokinetics of Dasatinib and the Effect of Dasatinib on Pharmacodynamic Markers in Patients With Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (planned)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of Segment 1 of the study is to determine the effect of ketoconazole on dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in patients with advanced solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dasatinib + Ketoconazole | Tablets, Oral, Segment 1: escalating single dose of dasatinib starting at 140 mg q24 hours on Day 1-8; single dose of ketoconazole 200 mg q12 hours on Days 3-8; Segment 2: single daily oral doses of dasatinib, once daily, until disease progression or unacceptable toxicity. |
Timeline
- Start date
- 2005-08-01
- Primary completion
- 2007-03-01
- Completion
- 2007-03-01
- First posted
- 2005-09-13
- Last updated
- 2011-04-14
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00162214. Inclusion in this directory is not an endorsement.