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Study of Dasatinib in Patients With Advanced Solid Tumors

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162214
First received: September 9, 2005
Last updated: April 13, 2011
Last verified: April 2011

September 9, 2005
April 13, 2011
August 2005
March 2007   (final data collection date for primary outcome measure)
  • 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
Segment 1: Determine whether the steady state pharmacokinetics of 20 mg of dasatanib are affected by co-administration with ketoconazole in patients with advanced solid tumors. Segment 2: Assess the pharmacodynamic activity of dasatinib
Complete list of historical versions of study NCT00162214 on ClinicalTrials.gov Archive Site
  • 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
Segment 1: Evaluate the safety and tolerability of dasatinib alone and when coadministered with ketoconazole. Segment 2: Explore the association between tumor response and the pre-clinically identified markers and other mRNA gene expression level
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tumors
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.
Other Name: Sprycel
Active Comparator: 1
Intervention: Drug: Dasatinib + Ketoconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00162214
CA180-021
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP