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. Identifier: NCT01799278
Recruitment Status : Completed
First Posted : February 26, 2013
Results First Posted : November 29, 2017
Last Update Posted : January 23, 2018
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Small Cell Prostate Cancer
Neuroendocrine Prostate Cancer
Prostate Adenocarcinoma Plus > 50% Immunohistochemical Staining for Neuroendocrine Markers
Intervention: Drug: MLN8237

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
All Patients MLN8237 at 50 mg twice daily for 7 days repeated every 21 days.

Participant Flow:   Overall Study
    All Patients

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
All Patients This is a 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

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (45 to 87) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
Female   0 
Male   60 
[1] All subjects are Male
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      4   6.7% 
Not Hispanic or Latino      50  83.3% 
Unknown or Not Reported      6  10.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      1   1.7% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2   3.3% 
White      49  81.7% 
More than one race      0   0.0% 
Unknown or Not Reported      8  13.3% 

  Outcome Measures

1.  Primary:   Response Rate, as Assessed by CT/MRI and Bone Scan, of Treatment With MLN8237 for Patients With Neuroendocrine Prostate Cancer   [ Time Frame: one year ]

2.  Secondary:   Progression-free Survival in Response to Therapy   [ Time Frame: 3 years ]

3.  Secondary:   Overall Survival in Response to Therapy   [ Time Frame: 3 years ]

4.  Secondary:   Prostate-Specific Antigen (PSA) Test Response Rate   [ Time Frame: 2 years ]

5.  Secondary:   Circulating Tumor Cell (CTC) Response   [ Time Frame: 2 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Himisha Beltran
Organization: Weill Cornell Medical College
phone: (646) 962-2072

Responsible Party: Weill Medical College of Cornell University Identifier: NCT01799278     History of Changes
Other Study ID Numbers: 1210013164
First Submitted: February 22, 2013
First Posted: February 26, 2013
Results First Submitted: October 30, 2017
Results First Posted: November 29, 2017
Last Update Posted: January 23, 2018