Study of Dasatinib in Patients With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Tumors

Treatments: Drug: Dasatinib + Ketoconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162214

CA180-021

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 1 patient group

1

Active Comparator group

Treatment:

Drug: Dasatinib + Ketoconazole