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

NCT01046916 | Completed Phase 2

• 1 other identifier: C21001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (5)

• To determine PSA response rate (PSA decline of at least 90%, 50% and 30% from baseline)at 3 and 6 months

  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

  6 months

• To determine time to PSA progression, time to metastases, and duration of progression-free survival

  Evidence of PSA or disease progression

• To monitor changes in endocrine markers

  Evidence of PSA or disease progression

• To evaluate the safety of TAK-700

  Evidence of PSA or disease progression

Study Arms (1)

TAK-700

EXPERIMENTAL

Drug: TAK-700

Interventions

TAK-700 DRUG

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

TAK-700

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (3)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• 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.

  PMID: 24965748 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

orteronel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 4, 2016

Record last verified: 2016-03

Locations

US (3)