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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
  Purpose

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:

MedlinePlus related topics: Cancer
Drug Information available for: Ixabepilone
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018966

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov 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:
Neoplasms
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013