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)
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 27, 2018 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Interventions being studied
- Drug: Alisertib; Drug: Placebo; Drug: Paclitaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Each participant must meet all the following inclusion criteria to be enrolled in the study: 1. Male or female participants ≥ 18 years old. 2. Have a pathologically (histology or cytology) confirmed diagnosis of SCLC. 3. Have received and progressed after a platinum-based standard chemotherapy regimen for first line treatment of SCLC, either limited stage (LS) or extensive stage (ES). 4. Have measurable disease within ≤ 2 weeks before randomization. Clear radiographic evidence of disease progression after initial therapy should have been documented. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (PS 0-1). 6. Participants with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the participant is off steroids or is on a stable dose of steroids. Participants should be without neurologic dysfunction that would confound the evaluation of neurological and/or other AEs.
Participants meeting any of the following
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Study locationLos Angeles, California
- Study locationSacramento, California
- Study locationNew Haven, Connecticut
- Study locationWashington D.C., District of Columbia
- Study locationBoca Raton, Florida
- Study locationHollywood, Florida
- Study locationOrlando, Florida
- Study locationTampa, Florida
- Study locationAtlanta, Georgia
- Study locationChicago, Illinois
- Study locationBoston, Massachusetts
- Study locationAnn Arbor, Michigan
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 27, 2018. Always confirm current availability with the study team.