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Safety and Efficacy Study of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer and a Rising Prostate-specific Antigen

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TAK-700
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria:

  • Male patients 18 years or older
  • Eastern Cooperative Oncology Group performance status 0-2
  • Male patients who Practice effective barrier contraception during study and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse.
  • Voluntary written consent
  • Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma without radiographic evidence of metastasis but with a rising PSA during or following the patient's most recent antineoplastic therapy despite castrate concentrations of testosterone
  • Baseline PSA must be greater than or equal to 2 ng/mL and PSA doubling time must be less than or equal to 8 months OR baseline PSA must be greater than or equal to 8 ng/mL if PSA doubling time is greater than 8 months
  • Has undergone orchiectomy or will continue receiving GnRH analogue therapy
  • Meet screening laboratory values as specified in protocol

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Known hypersensitivity to TAK-700 or related compounds
  • Received any of the following within 30 days prior to the first dose of TAK-700: any investigational compound; prior herbal product known to decrease PSA; radiation therapy for prostate cancer; OR chronic therapy with corticosteroids
  • Received prior therapy with aminoglutethimide or ketoconazole
  • Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to first dose of study drug
  • Received prior chemotherapy for prostate cancer
  • Current bladder neck outlet obstruction caused by prostate cancer, current spinal cord compression, or current bilateral hydronephrosis
  • Symptoms that investigator deems related to prostate cancer
  • Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
  • History of adrenal insufficiency
  • Uncontrolled cardiovascular condition
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
  • Unwilling or unable to comply with protocol
  • Major surgery or serious infection within 14 days of first dose of TAK-700
  • Life-threatening illness unrelated to cancer
  • Uncontrolled nausea, vomiting or diarrhea
  • Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of TAK-700

Sites / Locations

  • University of Michigan Comprehensive Cancer Center
  • Oregon Health and Sciences University
  • University of Wisconsin Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAK-700

Arm Description

Outcomes

Primary Outcome Measures

To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment

Secondary Outcome Measures

To determine PSA response rate (PSA decline of at least 90%, 50% and 30% from baseline)at 3 and 6 months
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 6 months of TAK-700 treatment
To determine time to PSA progression, time to metastases, and duration of progression-free survival
To monitor changes in endocrine markers
To evaluate the safety of TAK-700

Full Information

First Posted
January 11, 2010
Last Updated
March 4, 2016
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01046916
Brief Title
Safety and Efficacy Study of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer and a Rising Prostate-specific Antigen
Official Title
A Phase 2 Multicenter Open-label Study Evaluating the Safety and Efficacy of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer (CRPC) and a Rising Prostate-specific Antigen (PSA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAK-700
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TAK-700
Intervention Description
TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule
Primary Outcome Measure Information:
Title
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To determine PSA response rate (PSA decline of at least 90%, 50% and 30% from baseline)at 3 and 6 months
Time Frame
3 and 6 months
Title
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 6 months of TAK-700 treatment
Time Frame
6 months
Title
To determine time to PSA progression, time to metastases, and duration of progression-free survival
Time Frame
Evidence of PSA or disease progression
Title
To monitor changes in endocrine markers
Time Frame
Evidence of PSA or disease progression
Title
To evaluate the safety of TAK-700
Time Frame
Evidence of PSA or disease progression

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Each patient must meet all of the following inclusion criteria: Male patients 18 years or older Eastern Cooperative Oncology Group performance status 0-2 Male patients who Practice effective barrier contraception during study and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse. Voluntary written consent Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma without radiographic evidence of metastasis but with a rising PSA during or following the patient's most recent antineoplastic therapy despite castrate concentrations of testosterone Baseline PSA must be greater than or equal to 2 ng/mL and PSA doubling time must be less than or equal to 8 months OR baseline PSA must be greater than or equal to 8 ng/mL if PSA doubling time is greater than 8 months Has undergone orchiectomy or will continue receiving GnRH analogue therapy Meet screening laboratory values as specified in protocol Exclusion Criteria: Patients meeting any of the following exclusion criteria are not to be enrolled in the study: Known hypersensitivity to TAK-700 or related compounds Received any of the following within 30 days prior to the first dose of TAK-700: any investigational compound; prior herbal product known to decrease PSA; radiation therapy for prostate cancer; OR chronic therapy with corticosteroids Received prior therapy with aminoglutethimide or ketoconazole Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to first dose of study drug Received prior chemotherapy for prostate cancer Current bladder neck outlet obstruction caused by prostate cancer, current spinal cord compression, or current bilateral hydronephrosis Symptoms that investigator deems related to prostate cancer Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected History of adrenal insufficiency Uncontrolled cardiovascular condition Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C Unwilling or unable to comply with protocol Major surgery or serious infection within 14 days of first dose of TAK-700 Life-threatening illness unrelated to cancer Uncontrolled nausea, vomiting or diarrhea Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of TAK-700
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Millennium Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Wisconsin Hospitals and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24965748
Citation
Hussain M, Corn PG, Michaelson MD, Hammers HJ, Alumkal JJ, Ryan CJ, Bruce JY, Moran S, Lee SY, Lin HM, George DJ; Prostate Cancer Clinical Trials Consortium, a program of the Department of Defense Prostate Cancer Research Program and the Prostate Cancer Foundation. Phase II study of single-agent orteronel (TAK-700) in patients with nonmetastatic castration-resistant prostate cancer and rising prostate-specific antigen. Clin Cancer Res. 2014 Aug 15;20(16):4218-27. doi: 10.1158/1078-0432.CCR-14-0356. Epub 2014 Jun 25.
Results Reference
derived

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Safety and Efficacy Study of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer and a Rising Prostate-specific Antigen

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