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)

Millennium Pharmaceuticals, Inc0 sites178 target enrollmentApril 23, 2014

DrugsPaclitaxel 6 mg/ml concentrate for solution for infusion

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Millennium Pharmaceuticals, Inc
Enrollment: 178
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 23, 2014

End Date

July 10, 2017

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Millennium Pharmaceuticals, Inc

Eligibility Criteria

Inclusion Criteria

•1\. Male or female patients \= 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). Patients could not have received any prior second\-line therapy for relapsed or progressive disease, including re\-treatment with original frontline regimen. Patients should have relapsed within \< 180 days after their response to first line therapy. At least 3 weeks should have elapsed between the end of first line therapy and the first dose of study drug. No previous irradiation to the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression.
•4\. Have measurable disease per Response Evaluation Criteria in Solid Tumors, version 1\.1 (RECIST 1\.1\) 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\. Patients 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 patient is off steroids or is on a stable dose of steroids. Patients should be without neurologic dysfunction that would confound the evaluation of neurological and/or other AEs. Patients with brain metastases should not require use of enzyme\-inducing antiepileptic drugs (eg, carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug\-drug interactions (DDIs) is allowed. Radiotherapy must have been completed a minimum of 14 days prior to randomization, and patients must have recovered from AEs related to the radiotherapy to \< grade 1 (except alopecia).
•7\. Patients requiring full systemic anticoagulation are eligible if they have tolerated treatment with a stable dose and schedule without bleeding complications for more than 1 month.
•8\. Female patients who:
•Are postmenopausal for at least 1 year before the screening visit, OR
•Are surgically sterile, OR

Exclusion Criteria

•1\. Any prior therapy for second\-line treatment of SCLC.
•2\. Patients who relapsed \= 180 days after their response to first\-line treatment.
•3\. Prior treatment with an Aurora A specific\-targeted or pan\-Aurora\-targeted agent, including alisertib in any setting or any other investigational agent in the relapsed setting.
•4\. Prior treatment with paclitaxel or any other taxane agent.
•5\. Known hypersensitivity to Cremophor® EL, paclitaxel, or its components.
•6\. Any comorbid condition or unresolved toxicity that would preclude administration of alisertib or weekly paclitaxel.
•7\. Prior history of \= Grade 2 neurotoxicity that is not resolved to \= Grade 1\.
•8\. Patients with symptomatic and/or progressive brain metastases or with carcinomatous meningitis.
•9\. Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of alisertib and during study conduct. Major prohibited enzyme inducers include: phenytoin, carbamazepine, phenobarbital, rifampin, rifabutin, rifapentine, and St. John’s wort.
•10\. Inability to swallow alisertib or other orally administered medications.