First Line Study of Tamibarotene in Combination for Advanced Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT01337154|
Recruitment Status : Terminated (Interim analysis showed that the primary endpoint would not be met.)
First Posted : April 18, 2011
Last Update Posted : June 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Stage IIIB Non-small Cell Lung Cancer With Pleural Effusion Stage IV Non-small Cell Lung Cancer||Drug: Tamibarotene Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-Controlled Phase 2b Study of Tamibarotene Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin as First Line Treatment for Subjects With Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Subjects will receive tamibarotene, 6 mg/m2, divided as twice daily orally starting 1 week before chemotherapy and continuing through all 6 cycles and through the duration of the study. Chemotherapy will include paclitaxel (IV; 200 mg/m2) and carboplatin (IV; AUC=6)administered once every 3 weeks for up to 6 cycles.
Tablet, 6 mg/m2, oral, divided into twice a day dosing.
Placebo Comparator: Placebo
Subjects will take an equal number of placebo tablets as the group receiving tamibarotene divided as twice daily orally, starting 1 week before chemotherapy and continuing through all 6 cycles and through the duration of the study. Paclitaxel (IV; 200 mg/m2) and carboplatin (IV; AUC=6) will be administered once every 3 weeks for up to 6 cycles.
Tablets, orally, daily
- Progression-free survival [ Time Frame: Within 18 months of study start. ]Progression-free survival (PFS) is defined as the time from enrollment (i.e., assignment of subject ID number) to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.
- Objective response rate [ Time Frame: Within 18 months of study start. ]Objective tumor response will be evaluated using the RECIST 1.1 criteria.
- Overall survival [ Time Frame: Within 24 months of study start. ]
- Assessment of quality of life [ Time Frame: Within 24 months of study start. ]EORTC QLQ-C30 version 3.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337154
|Principal Investigator:||Oscar Arrieta, M.D.||Instituto Nacional de Cancerologia, Columbia|