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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:
R-Pharm
ClinicalTrials.gov Identifier:
NCT00162136
First received: September 9, 2005
Last updated: February 9, 2016
Last verified: February 2016

September 9, 2005
February 9, 2016
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 ]
Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for >14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia <25,000 cells/mm3 or bleeding requiring a platelet transfusion.
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 ]
    Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).
  • 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 ]
    Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).
  • 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 ]
    Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.)
  • 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 ]
    RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria.
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00162136
CA163-085
No
Not Provided
Not Provided
Study Director, Bristol-Myers Squibb
R-Pharm
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
R-Pharm
February 2016

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