A Phase II Trial of MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer
This study will evaluate the response rate of MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer (NEPC). MLN8237 is an orally administered Aurora kinase A inhibitor that has demonstrated broad antitumor activity in vitro and in vivo. In preclinical models, aurora kinase inhibition resulted in dramatic and preferential anti-tumor activity in NEPC with suppression of neuroendocrine marker expression.
Small Cell Prostate Cancer
Neuroendocrine Prostate Cancer
Prostate Adenocarcinoma Plus > 50% Immunohistochemical Staining for Neuroendocrine Markers
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer|
- Response rate, as assessed by CT/MRI and bone scan, of treatment with MLN8237 for patients with neuroendocrine prostate cancer [ Time Frame: one year ] [ Designated as safety issue: No ]To evaluate the objective response rate of MLN8237 for patients with neuroendocrine prostate cancer with CT/MRI and bone scan every three cycles. Response will be based on Recist criteria 1.1.
- Progression-free survival in response to therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]Patients will be followed for survival endpoints following completion of this study until death.
- Overall survival in response to therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]Patients will be followed for survival endpoints following completion of this study until death
- Prostate-Specific Antigen (PSA) test response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]PSA to be followed every cycle to determine response.
- Circulating Tumor Cell (CTC) response [ Time Frame: 2 years ] [ Designated as safety issue: No ]CTC counts by CellSearch will be performed at baseline, at 4-6 weeks, and upon progression to determine response.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Experimental: All Patients
MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent.
MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water.
Other Name: Alisertib
This is a multi-institutional single-arm, open-label Phase 2 trial evaluating MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer. Subjects will be treated with MLN8237 at 50 mg twice daily for 7 days repeated every 21 days. Individual dose reductions will be made on the basis of the AEs observed. Therapy will continue until disease progression, unacceptable toxicity as a result of MLN8237, or withdrawal of patient consent. Patients will be followed with history, physical, and blood tests at each visit to monitor for toxicity. Response and progression will be evaluated by CT/MRI scan and bone scan after every 3 cycles and determined using RECIST v1.1. PSA and serum chromogranin A and NSE will be followed every cycle. CTC counts by CellSearch will be performed at baseline, at 4-6 weeks, and upon progression. Patients will be followed for survival endpoints following completion of this study until death.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799278
|Contact: Lauren Emmerich, RNemail@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Patricia Yates 773-702-8923 firstname.lastname@example.org|
|Principal Investigator: David Vanderweele, MD|
|United States, Michigan|
|Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Tamara Kadoo, BS 313-576-9389 email@example.com|
|Principal Investigator: Ulka Vaishampayan, MD|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey||Recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Ruth Baumann, RN 732-235-7568 firstname.lastname@example.org|
|Principal Investigator: Mark Stein, MD|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Justine Anderson 646-667-3032 email@example.com|
|Principal Investigator: Daniel Danila, MD|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Lauren Emmerich, RN 212-746-1851 firstname.lastname@example.org|
|United States, North Carolina|
|Duke University Health System||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Carol Winters, RN 919-668-8577 Carolyn.email@example.com|
|Principal Investigator: Andrew Armstrong, MD|
|United States, Ohio|
|University Hospitals of Cleveland||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Donna Prots, RN 216-844-5393 donna.prots@UHHospitals.org|
|Principal Investigator: Christopher Hoimes, DO|
|United States, Washington|
|University of Washington Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Jina Taub, RN 206-288-7651 firstname.lastname@example.org|
|Principal Investigator: Bruce Montgomery, MD|
|Principal Investigator:||Himisha Beltran, MD||Weill Medical College of Cornell University|