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

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046916
• Other study ID #: C21001
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2010
• Last updated: November 15, 2013
• Start date: May 2010
• Est. completion date: March 2013

Study information

• Verified date: November 2013
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	University of Wisconsin Hospitals and Clinics	Madison	Wisconsin
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	To determine time to PSA progression, time to metastases, and duration of progression-free survival		Evidence of PSA or disease progression	No
Secondary	To monitor changes in endocrine markers		Evidence of PSA or disease progression	No
Secondary	To evaluate the safety of TAK-700		Evidence of PSA or disease progression	Yes