Study of Dasatinib in Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Dasatinib + Ketoconazole

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Sprycel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No