Trials / Terminated
TerminatedNCT01337154
First Line Study of Tamibarotene in Combination for Advanced Non-Small Cell Lung Cancer
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- CytRx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to determine the progression-free survival and objective response rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who are treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or placebo. Subjects will be randomly assigned to receive tamibarotene, 6 mg/m2, divided as twice daily orally, or an equal number of matching placebo tablets, starting 1 week before chemotherapy and continuing through all 6 cycles and beyond. Subjects will be assessed for response on Day 50, Day 113, then every other month using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tamibarotene | Tablet, 6 mg/m2, oral, divided into twice a day dosing. |
| DRUG | Placebo | Tablets, orally, daily |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2011-04-18
- Last updated
- 2013-06-28
Locations
26 sites across 6 countries: United States, Bulgaria, India, Mexico, Russia, Ukraine
Source: ClinicalTrials.gov record NCT01337154. Inclusion in this directory is not an endorsement.