Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

This study has been completed.

Study NCT00050960 Information provided by Eisai Inc.

First Received on December 31, 2002. Last Updated on July 23, 2010 History of Changes

Results First Received: July 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Non-small Cell Lung Cancer
Interventions:	Drug: bexarotene with carboplatin and paclitaxel Drug: carboplatin and paclitaxel

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
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Reporting Groups

	Description
Bexarotene With Carboplatin and Paclitaxel	bexarotene capsules in combination with carboplatin IV and paclitaxel IV
Carboplatin and Paclitaxel	carboplatin IV and paclitaxel IV

Participant Flow: Overall Study

	Bexarotene With Carboplatin and Paclitaxel	Carboplatin and Paclitaxel
STARTED	306	306
COMPLETED	4 ^[1]	2 ^[1]
NOT COMPLETED	302	304
Progressive Disease	137	93
Stable Disease	19	48
Partial Response	14	19
Complete Response	0	2
Adverse Event	62	61
Lost to Follow-up	0	1
Withdrawal by Subject	23	18
Administrative	31	46
Non-compliance	3	1
Death	13	15

[1]	Represents number of patients with no primary reason for termination

Baseline Characteristics

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Reporting Groups

	Description
Bexarotene With Carboplatin and Paclitaxel	bexarotene capsules in combination with carboplatin IV and paclitaxel IV
Carboplatin and Paclitaxel	carboplatin IV and paclitaxel IV

Baseline Measures

	Bexarotene With Carboplatin and Paclitaxel	Carboplatin and Paclitaxel	Total
Number of Participants [units: participants]	306	306	612
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	166	174	340
>=65 years	140	132	272
Age [units: years] Mean ± Standard Deviation	62.5 ± 9.6	61.7 ± 10.3	62.1 ± 10.0
Gender [units: participants]
Female	103	103	206
Male	203	203	406
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	2	9	11
Not Hispanic or Latino	304	297	601
Unknown or Not Reported	0	0	0
Race (NIH/OMB) ^[1] [units: Participants]
American Indian or Alaska Native	0	0	0
Asian	7	3	10
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	23	20	43
White	269	272	541
More than one race	0	0	0
Unknown or Not Reported	5	2	7

[1]	Counts are correct as reported. The BL measure title of "race" does not include counts of Hispanic or Latino population- which are reported in the BL measure title of "Ethnicity."

Outcome Measures

1. Primary:

Overall Survival [ Time Frame: From date of randomization to date of death ]

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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 NOT 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.

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: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743

No publications provided

Responsible Party:	Eisai, Inc
ClinicalTrials.gov Identifier:	NCT00050960 History of Changes
Obsolete Identifiers:	NCT00036907
Other Study ID Numbers:	L1069-48
Study First Received:	December 31, 2002
Results First Received:	July 23, 2010
Last Updated:	July 23, 2010
Health Authority:	United States: Food and Drug Administration