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

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

Interventions

  • Drug: TAK-700
    • TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule

Arms, Groups and Cohorts

  • Experimental: TAK-700

Clinical Trial Outcome Measures

Primary 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

Secondary 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
  • 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
  • To determine time to PSA progression, time to metastases, and duration of progression-free survival
    • Time Frame: Evidence of PSA or disease progression
  • To monitor changes in endocrine markers
    • Time Frame: Evidence of PSA or disease progression
  • To evaluate the safety of TAK-700
    • Time Frame: Evidence of PSA or disease progression

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Millennium Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Millennium Pharmaceuticals, Inc.

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