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Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162136
First received: September 9, 2005
Last updated: December 22, 2009
Last verified: December 2009
History of Changes

September 9, 2005
December 22, 2009
September 2005
July 2008   (final data collection date for primary outcome measure)
Number of Participants With Dose Limiting Toxicities at Dose Level [ Time Frame: Measures taken at Cycle 01 (21-day cycle) ] [ Designated as safety issue: Yes ]
To Define the DLT, MTD, and recommended dose for Phase II. Measures will be taken at Cycle 01(Dose Escalation)
Complete list of historical versions of study NCT00162136 on ClinicalTrials.gov Archive Site
  • Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation [ Time Frame: From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities. ] [ Designated as safety issue: Yes ]
  • Hematology Results - Worst On-Study Grade [ Time Frame: Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution. ] [ Designated as safety issue: Yes ]
  • Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level [ Time Frame: through 72 hours after start of infusion ] [ Designated as safety issue: No ]
  • Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles. ] [ Designated as safety issue: No ]
Safety and tolerability of Cremophor free infusion of ixabepilone given over 24 hours. Done throughout the study.
Not Provided
Not Provided
 
Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.
Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies

The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Malignancies
Drug: Ixabepilone
Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
Other Name: IXEMPRA®
Experimental: A1
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
35
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • confirmed diagnosis of a primary solid tumor
  • measurable or non-measurable disease
  • progressive disease
  • men and women greater or equal to 18 years of age.

Exclusion Criteria:

  • women of child bearing potential who are not using birth control
  • women who are pregnant or breast feeding
  • women with a positive pregnancy test on enrollment
  • patients with brain metastasis
  • prior treatment with Ixabepilone
  • known history of human immunodeficiency virus (HIV)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00162136
CA163-085
No
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