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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAK-700

Group Type EXPERIMENTAL

TAK-700

Intervention Type DRUG

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

Interventions

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TAK-700

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

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No