Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00683904

First received: May 22, 2008

Last updated: March 15, 2011

Last verified: March 2011

History of Changes

Results First Received: February 8, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Carcinoma, Non-Small-Cell Lung
Interventions:	Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After all participants in Dose Level 1 (ixabepilone, 32 mg/m^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2 (ixabepilone, 32 mg/m^2 + carboplatin, 6 mg/min/mL) opened.

Reporting Groups

	Description
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL	Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL	After all participants in Dose Level 1 have been observed for 1 full 21-day cycle, Dose Level 2 opened: Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL. infused over 30 minutes on Day 1 of each 21-day cycle.

Participant Flow for 2 periods

Period 1: Dose Level 1

	Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL	Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
STARTED	6	0
COMPLETED	3	0
NOT COMPLETED	3	0
Disease progression	2	0
Adverse Event	1	0

Period 2: Dose Level 2

	Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL	Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
STARTED	0	6
COMPLETED	0	4
NOT COMPLETED	0	2
Adverse Event	0	2

Baseline Characteristics

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Reporting Groups

	Description
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL	Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL	Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
Total	Total of all reporting groups

Baseline Measures

	Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL	Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL	Total
Number of Participants [units: participants]	6	6	12
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	6	4	10
>=65 years	0	2	2
Age [units: years] Mean ± Standard Deviation	51.2 ± 8.30	57.7 ± 10.5	54.4 ± 9.62
Gender [units: participants]
Female	4	3	7
Male	2	3	5
Race/Ethnicity, Customized [units: Participants]
Hispanic or Latino	0	0	0
Not Hispanic or Latino	0	0	0
Unknown or Not Reported	0	0	0
Japanese	6	6	12

Outcome Measures

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1. Primary:

Number of Participants With Dose-limiting Toxicity (DLT) [ Time Frame: Days 1 through 21 (Cycle 1) ]

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2. Primary:

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2 [ Time Frame: Days 1 through 21 (Cycle 1) ]

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3. Secondary:

Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation [ Time Frame: Days 1 through 21 (Cycle 1) ]

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4. Secondary:

Number of Participants With Grade 3 or Greater Treatment-related AEs [ Time Frame: Days 1 through 21 (Cycle 1) ]

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5. Secondary:

Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade [ Time Frame: At screening and Days 8 and 15 of Cycle 1 (21 days) ]

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6. Secondary:

Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade [ Time Frame: At screening and Days 8 and 15 of Cycle 1 (21 days) ]

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7. Secondary:

Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade [ Time Frame: At screening and Days 8 and 15 of Cycle 1 (21 days) ]

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8. Secondary:

Number of Participants With Abnormalities in Blood Pressure and Heart Rate [ Time Frame: At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22) ]

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9. Secondary:

Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22) ]

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10. Secondary:

Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment [ Time Frame: Days 1 through 21 (Cycle 1) ]

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11. Secondary:

Maximum Observed Plasma Concentration of Ixabepilone [ Time Frame: Days 1 to 8 of Cycle 1 (21 days) ]

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12. Secondary:

Time of Maximum Observed Plasma Concentration of Ixabepilone [ Time Frame: Days 1 to 8 of Cycle 1 (21 days) ]

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13. Secondary:

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone [ Time Frame: Days 1 to 8 of Cycle 1 (21 days) ]

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14. Secondary:

Volume of Distribution at Steady State of Ixabepilone [ Time Frame: Days 1 to 8 of Cycle 1 (21 days) ]

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15. Secondary:

Total Body Clearance of Ixabepilone [ Time Frame: Days 1 to 8 of Cycle 1 (21 days) ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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
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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:	NCT00683904 History of Changes
Other Study ID Numbers:	CA163-160
Study First Received:	May 22, 2008
Results First Received:	February 8, 2011
Last Updated:	March 15, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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