A Phase II Trial of MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01799278|
Recruitment Status : Completed
First Posted : February 26, 2013
Results First Posted : November 29, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Prostate Cancer Neuroendocrine Prostate Cancer Prostate Adenocarcinoma Plus > 50% Immunohistochemical Staining for Neuroendocrine Markers||Drug: MLN8237||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer|
|Actual Study Start Date :||February 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||August 2017|
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
- Response Rate, as Assessed by CT/MRI and Bone Scan, of Treatment With MLN8237 for Patients With Neuroendocrine Prostate Cancer [ Time Frame: one year ]Evaluated per RECIST 1.1 guidelines: Complete response (CR) is defined as complete disappearance of all measurable and evaluable lesions by physical examination or imaging studies and normalization of PSA with no appearance of new lesions for > 1 month. Partial response (PR) is defined as a 30% 56 or greater reduction in the sum longest unidimensional diameter of all measurable lesions. There may be no new lesions. Stable Disease (SD) is characterized by patients who do not meet the criteria of PR and who are without signs of progressive disease for at least 1 month. Disease Progression (DP) is defined as a greater than 20% increase in the sum longest unidimensional diameters of the indicator lesions or the appearance of new lesions. Bone scan progression (evaluable disease only) is defined by PCWG2 criteria. Per consensus guidelines in CRPC, to be considered measurable, lymph nodes need to be at least 2 cm in greatest dimension and 1.5 cm in short axis.
- Progression-free Survival in Response to Therapy [ Time Frame: 3 years ]Patients will be followed for survival endpoints following completion of this study until death.
- Overall Survival in Response to Therapy [ Time Frame: 3 years ]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 ]PSA to be followed every cycle to determine response.
- Circulating Tumor Cell (CTC) Response [ Time Frame: 2 years ]CTC counts by CellSearch will be performed at baseline, at 4-6 weeks, and upon progression to determine response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799278
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Himisha Beltran, MD||Weill Medical College of Cornell University|