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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
Results First Received: July 3, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Solid Malignancies
Intervention: Drug: Ixabepilone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 39 participants enrolled and 4 participants were never treated (2 reported serious adverse events [SAEs] prior to the first dose of study medication and were never treated; 1 had rapid decline in performance status and died prior to the first dose of study medication; no reason was given for the remaining participant).

Reporting Groups
  Description
Ixabepilone Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles

Participant Flow:   Overall Study
    Ixabepilone  
STARTED     35  
COMPLETED     0 [1]
NOT COMPLETED     35  
Adverse Event                 1  
Death                 1  
Disease Progression/Relapse                 23  
Investigator Request                 5  
Study Drug Toxicity                 4  
Withdrawal by Subject                 1  
[1] Number of Participants still on treatment at study termination



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
10 mg/m2 Ixabepilone
20 mg/m2 Ixabepilone
30 mg/m2 Ixabepilone
35 mg/m2 Ixabepilone
40 mg/m2 Ixabepilone
45 mg/m2 Ixabepilone
Total Total of all reporting groups

Baseline Measures
    10 mg/m2     20 mg/m2     30 mg/m2     35 mg/m2     40 mg/m2     45 mg/m2     Total  
Number of Participants  
[units: participants]
  4     3     8     4     11     5     35  
Age  
[units: years]
Mean ( Full Range )
  63.5  
  ( 54 to 74 )  
  59.0  
  ( 58 to 64 )  
  61.5  
  ( 39 to 70 )  
  59.5  
  ( 53 to 62 )  
  58.0  
  ( 53 to 79 )  
  52.0  
  ( 40 to 60 )  
  59.0  
  ( 39 to 79 )  
Gender  
[units: participants]
             
Female     1     0     5     2     5     3     16  
Male     3     3     3     2     6     2     19  
Race/Ethnicity, Customized  
[units: participants]
             
White     3     2     7     3     9     2     26  
Black     0     1     0     1     1     2     5  
Asian     1     0     1     0     1     1     4  
Karnofsky Performance Status [1]
[units: participants]
             
90 to 100     2     2     6     2     7     3     22  
70 to 80     2     1     2     2     4     2     13  
0 to 60     0     0     0     0     0     0     0  
[1] The Karnofsky Performance Status (KPS) measures the ability of cancer patients to perform ordinary tasks. Scores are reported in multiples of 10 and range from 0 to 100; a higher score means the patient is better able to carry out daily activities.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Dose Limiting Toxicities at Dose Level   [ Time Frame: Measures taken at Cycle 01 (21-day cycle) ]

2.  Secondary:   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. ]

3.  Secondary:   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. ]

4.  Secondary:   Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level   [ Time Frame: through 72 hours after start of infusion ]

5.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00162136     History of Changes
Other Study ID Numbers: CA163-085
Study First Received: September 9, 2005
Results First Received: July 3, 2009
Last Updated: December 22, 2009
Health Authority: United States: Food and Drug Administration