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

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: November 24, 2009
Last updated: December 16, 2009
Last verified: December 2009
The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.

Condition Intervention Phase
Solid Tumors
Drug: Ixabepilone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: April 2004
Study Completion Date: April 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ixabepilone Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)
Other Names:
  • Ixempra
  • BMS-247550


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01018966

Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT01018966     History of Changes
Other Study ID Numbers: CA163-029 
Study First Received: November 24, 2009
Last Updated: December 16, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on January 14, 2017