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

Sponsor

Millennium Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01046916

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

12.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: TAK-700	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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 Start Date :

May 1, 2010

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAK-700	Drug: TAK-700 TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule

Arm

Intervention/Treatment

Experimental: TAK-700

Drug: TAK-700

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

Outcome Measures

Primary Outcome 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 [3 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
2	Oregon Health and Sciences University	Portland	Oregon	United States	97239
3	University of Wisconsin Hospitals and Clinics	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

Study Director: Medical Monitor, Millennium Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Millennium Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01046916

Other Study ID Numbers:

C21001

First Posted:

Jan 12, 2010

Last Update Posted:

Apr 4, 2016

Last Verified:

Mar 1, 2016

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Apr 4, 2016