Tumors
Conditions
Keywords
Advanced Solid Tumors
Brief 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.
Interventions
DRUGDasatinib + 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.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ECOG status 0-2 * Advanced or metastatic disease, unresponsive to standard treatment (or no standard treatment exists) * Biopsy pretreatment * Adequate bone marrow, liver and kidney function
Exclusion criteria
* Serious cardiovascular disease * Bleeding disorders * Gastrointestinal (GI) tract disease * Platelet inhibitors * H2 blockers, proton pump inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Segment 1: Determine whether the steady state pharmacokinetics of 20 mg of dasatinib are affected by co-administration with ketoconazole in patients with advanced solid tumors | — |
| Segment 2: Assess the pharmacodynamic activity of dasatinib | — |
Secondary
| Measure | Time frame |
|---|---|
| Segment 1: Evaluate the safety and tolerability of dasatinib alone and when co-administered with ketoconazole | — |
| Segment 2: Explore the association between tumor response and the pre-clinically identified markers and other mRNA gene expression level | — |
Countries
United States
Outcome results
None listed