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Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01018966
First received: November 24, 2009
Last updated: December 16, 2009
Last verified: December 2009
History of Changes

November 24, 2009
December 16, 2009
April 2004
March 2005   (final data collection date for primary outcome measure)
To establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT) [ Time Frame: 3-week treatment cycles until unacceptable toxicity ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01018966 on ClinicalTrials.gov Archive Site
  • To evaluate safety by assessing adverse events. Toxicity will be evaluated according to the Common Toxicity Criteria Version 3.0 (CTC). Response will be evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria [ Time Frame: 3-week treatment cycles ] [ Designated as safety issue: Yes ]
  • To evaluate the plasma pharmacokinetics of Ixabepilone according to the following parameters: Cmax, AUC(INF), Tmax, t1/2, MRT(INF), Vss, Cltot [ Time Frame: Cycle 1 (first 3 weeks of study therapy) ] [ Designated as safety issue: No ]
  • To describe any preliminary evidence of anti-tumor activity (response), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 3-week treatment cycles until unacceptable toxicity ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors
Phase I Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)
Other Names:
  • Ixempra
  • BMS-247550
Experimental: Ixabepilone
Intervention: Drug: Ixabepilone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
April 2005
March 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 20 years or older
  • Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors

Exclusion Criteria:

  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01018966
CA163-029
Yes
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2009

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