Trial record 1 of 1 for:    SWOG S1216
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S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Southwest Oncology Group
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01809691
First received: March 8, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.


Condition Intervention Phase
Prostate Cancer
Drug: TAK-700
Drug: Bicalutamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 3.2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1486
Study Start Date: March 2013
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADT + TAK-700

LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.

TAK-700, 300 mg, PO, twice daily

Drug: TAK-700
300 mg, PO, twice daily
Other Name: Orteronel
Active Comparator: ADT + Bicalutamide

LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.

Bicalutamide, 50 mg, PO, q daily

Drug: Bicalutamide
50 mg, PO, q daily
Other Name: Casodex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of metastatic prostate cancer.
  • Serum testosterone within institutional limits of normal.
  • PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).
  • DEXA scan within 2 years prior to registration.
  • ECG within 42 days prior to registration and QTc interval ≤ 460 msec.
  • LVEF within 42 days prior to registration and within institutional limits of normal.
  • Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.
  • Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.
  • Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.
  • Zubrod performance status of 0 - 2. Zubrod performance status 3 will be allowed if from bone pain only.
  • ≥ 18 years of age.
  • Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.

Exclusion Criteria:

  • Known brain metastases.
  • No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.
  • ≥ 6 months since completion of androgen deprivation therapy.
  • Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
  • Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.
  • ≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.
  • Concurrent use of experimental therapy is not allowed.
  • ≥ 30 days since prior medical castration for metastatic prostate cancer.
  • If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.
  • If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).
  • Prior bilateral orchiectomy.
  • Concurrent use of LHRH antagonists (e.g. Degarelix)
  • Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
  • Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.
  • Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.
  • History of primary and secondary adrenal insufficiency.
  • Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.
  • Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
  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: NCT01809691

Contacts
Contact: Gilbert R. Carrizales, M.S. 614-8808 ext 1027 gcarrizales@swog.org
Contact: Dana B. Sparks, M.A.T. 614-8808 ext 1004 dsparks@swog.org

  Show 272 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Neeraj Agarwal, M.D. University of Utah
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01809691     History of Changes
Other Study ID Numbers: S1216, SWOG-S1216, NCI-2012-02876
Study First Received: March 8, 2013
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
Prostate cancer
TAK-700
Bicalutamide
S1216
androgen therapy
Phase III

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgens
Bicalutamide
Androgen Antagonists
Antineoplastic Agents
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014