Phase 1 Trial of Oral Ixabepilone

This study has been terminated.
(Business Objectives Changed)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00632424
First received: March 3, 2008
Last updated: November 4, 2010
Last verified: November 2010
Results First Received: September 15, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Advanced Solid Tumors
Intervention: Drug: Ixabepilone (oral formulation)

  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
23 participants enrolled in this study; five participants were never treated due to not meeting study criteria (n=4) and withdrawal of consent (n=1).

Reporting Groups
  Description
All Treated Participants Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle.

Participant Flow:   Overall Study
    All Treated Participants  
STARTED     18  
COMPLETED     0  
NOT COMPLETED     18  
Disease Progression                 17  
Study Drug Toxicity                 1  



  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
Ixabepilone 90 mg/Day The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
Ixabepilone 120 mg/Day Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
Ixabepilone 150 mg/Day Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
Total Total of all reporting groups

Baseline Measures
    Ixabepilone 90 mg/Day     Ixabepilone 120 mg/Day     Ixabepilone 150 mg/Day     Total  
Number of Participants  
[units: participants]
  3     9     6     18  
Age  
[units: participants]
       
<65 years     2     4     6     12  
≥65 years     1     5     0     6  
Age  
[units: years]
Median ( Full Range )
  59.0  
  ( 47.0 to 70.0 )  
  69.0  
  ( 39.0 to 75.0 )  
  56.0  
  ( 27.0 to 60.0 )  
  59.0  
  ( 27.0 to 75.0 )  
Gender  
[units: participants]
       
Female     2     5     3     10  
Male     1     4     3     8  



  Outcome Measures
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1.  Primary:   Number of Participants With a Dose-Limiting Toxicity (DLT)   [ Time Frame: During Cycle 1 (Day 0 through Day 21) ]

2.  Primary:   Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)   [ Time Frame: At the end of Cycle 1 (21 days). ]

3.  Secondary:   Number of Participants With Adverse Event (AE), AE Leading to Discontinuation, Treatment-related AE, Treatment-related AE Leading to Discontinuation (DC), Most Common Treatment-Related Nonhematologic AE (>25%), Serious AE (SAE), or Treatment-related SAE   [ Time Frame: From first study drug administration through 30 days post dose ]

4.  Secondary:   Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)   [ Time Frame: From first study drug administration through 30 days post dose ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)
Measure Description AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.
Time Frame From first study drug administration through 30 days post dose  
Safety Issue Yes  

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.
All participants who received at least one dose of ixabepilone.

Reporting Groups
  Description
All Treated Participants Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle

Measured Values
    All Treated Participants  
Number of Participants Analyzed  
[units: participants]
  18  
Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)  
[units: participants]
 
Gr 1 (mild) Fatigue     4  
Gr 2 (moderate) Fatigue     3  
Gr 4 (LT) Fatigue     1  
All Fatigue     8  
Gr 1 (mild) Nausea     7  
All Nausea     7  

No statistical analysis provided for Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)



5.  Secondary:   Number of Participants With Hematology Laboratory Abnormalities   [ Time Frame: From first study drug administration through 30 days post dose ]

6.  Secondary:   Number Of Participants With Liver Function and Renal Laboratory Abnormalities   [ Time Frame: From first study drug administration through 30 days post dose ]

7.  Secondary:   Maximum QTc Interval on Day 1 and Maximum Change From Baseline for QTc Interval   [ Time Frame: Baseline (Day -1) and Day 1 ]

8.  Secondary:   PK: Mean Plasma Concentration Of Ixabepilone By Nominal Collection Time   [ Time Frame: Time 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 12.5, 13, 14, 15, 16, 17, 18, 20, 48, 72, and 168 hours post dose ]

9.  Secondary:   Best Overall Response   [ Time Frame: Tumor assessments performed on Day 1 of every other cycle of therapy, until disease progression or toxicity ]


  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
The MTD of oral ixabepilone at the scheduled doses used in this study was not determined due to early study discontinuation.


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