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)

Millennium Pharmaceuticals, Inc.3 sites in 1 country38 target enrollmentMay 2010

ConditionsProstate Cancer

InterventionsTAK-700

DrugsTAK-700

Overview

Phase: Phase 2
Intervention: TAK-700
Conditions: Prostate Cancer
Sponsor: Millennium Pharmaceuticals, Inc.
Enrollment: 38
Locations: 3
Primary Endpoint: 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
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

March 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Millennium Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

TAK-700

Intervention: TAK-700

Outcomes

Primary Outcomes

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 Outcomes

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)