Phase I Combination Ixabepilone + Cisplatin

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00832117

First received: January 28, 2009

Last updated: March 24, 2012

Last verified: March 2012

History of Changes

Results First Received: February 21, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Non Small Cell Lung Cancer
Interventions:	Drug: Ixabepilone Drug: Cisplatin

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
A total of 30 participants were enrolled; 29 were treated (1 participant no longer met study criteria).

Reporting Groups

	Description
All Enrolled Participants	Participants received both ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 and ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle.

Participant Flow: Overall Study

	All Enrolled Participants
STARTED	29
COMPLETED	17
NOT COMPLETED	12
Death	1
Disease Progression	11

Baseline Characteristics

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Reporting Groups

	Description
Ixa 32 mg/m^2+Cis 60 mg/m^2	6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
32mg/m^2+Cis 80mg/m^2	5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
Total	Total of all reporting groups

Baseline Measures

	Ixa 32 mg/m^2+Cis 60 mg/m^2	32mg/m^2+Cis 80mg/m^2	Total
Number of Participants [units: participants]	24	5	29
Age [units: years] Median ( Full Range )	64 ( 33 to 77 )	54 ( 30 to 61 )	63 ( 30 to 77 )
Age, Customized [units: participants]
< 65 years	12	5	17
>= 65 years	12	0	12
< 50 years	3	2	5
>= 50 years	21	3	24
Gender [units: participants]
Female	10	2	12
Male	14	3	17
Karnofsky Performance Status ^[1] [units: participants]
80 - Activity with effort; some signs of disease	9	2	11
90 - Normal activity; minor signs of disease	2	1	3
100 - Normal no complaints; no evidence of disease	13	2	15

[1]	Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses.

Outcome Measures

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1. Primary:

Participants Experiencing Dose Limiting Toxicity (DLT) [ Time Frame: Within the first 21 days of first cycle ]

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2. Primary:

Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2 [ Time Frame: Within the first 21 days of first cycle ]

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Measure Type	Primary
Measure Title	Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2
Measure Description	The MTD is defined as the highest dose level in which dose limiting toxicities (DLTs) during the first 21 days of the first treatment cycle are observed in less than 1 out of 3 or less than 2 out of 6 treated subjects with at least 2 subjects experiencing DLT at the next higher dose level.
Time Frame	Within the first 21 days of first cycle
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 subjects who received at least 1 dose of either ixabepilone or carboplatin

Reporting Groups

	Description
All Treated Participants	All participants who received at least 1 dose of either ixabepilone or carboplatin

Measured Values

	All Treated Participants
Number of Participants Analyzed [units: participants]	29
Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2 [units: mg/m^2]	60

No statistical analysis provided for Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2

3. Secondary:

Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm. ]

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4. Secondary:

Percentage of Participants With Response [ Time Frame: At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm. ]

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5. Secondary:

Duration of Response in Participants With Non-small Cell Lung Cancer (NSCLC) [ Time Frame: The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. (Duration of study was approximately 21 months.) ]

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6. Secondary:

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria [ Time Frame: Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2. ]

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7. Secondary:

Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria [ Time Frame: Assessed at screening and weekly during treatment. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2. ]

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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:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00832117 History of Changes
Other Study ID Numbers:	CA163-177, 2008-004909-34
Study First Received:	January 28, 2009
Results First Received:	February 21, 2012
Last Updated:	March 24, 2012
Health Authority:	United States: Food and Drug Administration Italy: Ministry of Health

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