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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01046916
First received: January 11, 2010
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Drug: TAK-700
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine time to PSA progression, time to metastases, and duration of progression-free survival [ Time Frame: Evidence of PSA or disease progression ] [ Designated as safety issue: No ]
  • To monitor changes in endocrine markers [ Time Frame: Evidence of PSA or disease progression ] [ Designated as safety issue: No ]
  • To evaluate the safety of TAK-700 [ Time Frame: Evidence of PSA or disease progression ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: May 2010
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-700 Drug: TAK-700
TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046916

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
United States, Wisconsin
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01046916     History of Changes
Other Study ID Numbers: C21001
Study First Received: January 11, 2010
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014