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Study of Dasatinib in Patients With Advanced Solid Tumors

Bristol-Myers Squibb (BMS) logo

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)

60 participants in 1 patient group

1
Active Comparator group
Treatment:
Drug: Dasatinib + Ketoconazole

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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