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

History of Changes

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

Hide Participant Flow

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

Hide Baseline Characteristics

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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Primary:

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

Show Outcome Measure 2

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 ]

Show Outcome Measure 3

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 ]

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Limitations and Caveats

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.

Results Point of Contact:

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

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00632424 History of Changes
Other Study ID Numbers:	CA163-149
Study First Received:	March 3, 2008
Results First Received:	September 15, 2010
Last Updated:	November 4, 2010
Health Authority:	United States: Food and Drug Administration

To Top