Clinical Trial: NCT02038647
Phase 2 Study of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC)
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Millennium Pharmaceuticals, Inc. |
| Information Provided By: | Takeda |
| Last Update Posted: | 2018-12-27 |
Study Overview
Brief Summary
This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study designed to is to determine if the combination treatment can improve progression free survival (defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first) when compared with placebo + paclitaxel.
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC).
Conditions
Small Cell Lung Cancer
Intervention / Treatment
- Drug: Alisertib
- Drug: Placebo
- Drug: Paclitaxel
Other Study ID Numbers
- C14018
- 2013-003713-18
- U1111-1154-9805
- DRKS00007849
Start Date (Actual)
2014-05-12
Primary Completion Date (Actual)
2016-01-03
Study Completion Date (Actual)
2017-07-10
Enrollment (Actual)
178
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Millennium Pharmaceuticals, Inc. |
| Information Provided By: | Takeda |
| Last Update Posted: | 2018-12-27 |
Study Overview
Brief Summary
This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study designed to is to determine if the combination treatment can improve progression free survival (defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first) when compared with placebo + paclitaxel.
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC).
Conditions
Small Cell Lung Cancer
Intervention / Treatment
- Drug: Alisertib
- Drug: Placebo
- Drug: Paclitaxel
Other Study ID Numbers
- C14018
- 2013-003713-18
- U1111-1154-9805
- DRKS00007849
Start Date (Actual)
2014-05-12
Primary Completion Date (Actual)
2016-01-03
Study Completion Date (Actual)
2017-07-10
Enrollment (Actual)
178
Study Type
Interventional
Phase
Phase 2