Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

NCT ID: NCT01084655

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2016-03-31

Brief Summary

This is an open-label, multicenter, Phase 1/2 study of TAK-700 in combination with docetaxel and prednisone that will evaluate the safety and pharmacokinetics (PK) of the combination and will allow estimation of prostate-specific antigen (PSA) response in men with metastatic castration-resistant prostate cancer (mCRPC).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone

Orteronel (TAK-700) 200 milligram (mg), tablets, orally, twice daily (BID) starting from Day 1 along with docetaxel 75 milligram per square meter (mg/m\^2), infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.

Group Type: EXPERIMENTAL

TAK-700

Intervention Type: DRUG

TAK-700 with docetaxel and prednisone on a continuous schedule.

Docetaxel

Intervention Type: DRUG

TAK-700 with docetaxel and prednisone on a continuous schedule.

Prednisone

Intervention Type: DRUG

TAK-700 with docetaxel and prednisone on a continuous schedule.

Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone

Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m\^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods.

Group Type: EXPERIMENTAL

TAK-700

Intervention Type: DRUG

TAK-700 with docetaxel and prednisone on a continuous schedule.

Docetaxel

Intervention Type: DRUG

TAK-700 with docetaxel and prednisone on a continuous schedule.

Prednisone

Intervention Type: DRUG

TAK-700 with docetaxel and prednisone on a continuous schedule.

Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone

Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15 along with docetaxel 75 mg/m\^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT).

Group Type: EXPERIMENTAL

TAK-700

Intervention Type: DRUG

TAK-700 with docetaxel and prednisone on a continuous schedule.

Docetaxel

Intervention Type: DRUG

TAK-700 with docetaxel and prednisone on a continuous schedule.

Prednisone

Intervention Type: DRUG

TAK-700 with docetaxel and prednisone on a continuous schedule.

Interventions

TAK-700

TAK-700 with docetaxel and prednisone on a continuous schedule.

Intervention Type: DRUG

Docetaxel

TAK-700 with docetaxel and prednisone on a continuous schedule.

Intervention Type: DRUG

Prednisone

TAK-700 with docetaxel and prednisone on a continuous schedule.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Voluntary written consent
• Male patients 18 years or older
• Estimated life expectancy of 6 months or more
• Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
• Radiograph-documented metastatic disease
• Progressive disease
• Prior surgical castration or concurrent use of an agent for medical castration
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria

• Even if surgically sterilized, patients must Practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug, OR Abstain from heterosexual intercourse
• Any use of opiates must be stable for at least 2 weeks prior to study entry
• Meet screening laboratory values as specified in protocol
• Suitable venous access

• Known hypersensitivity to TAK-700, docetaxel, prednisone or related compounds
• Received any of the following within 30 days prior to the first dose of TAK-700: prior therapy with any investigational compound; prior herbal product known to decrease PSA; OR radiation therapy for prostate cancer
• Received prior therapy with TAK-700, aminoglutethimide, ketoconazole or abiraterone (for Phase 1 only, patients previously treated with ketoconazole or abiraterone will be eligible if treatment with ketoconazole or abiraterone was discontinued at least 30 days prior to enrollment)
• 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 spinal cord compression, bilateral hydronephrosis or neck outlet obstruction
• 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
• Uncontrolled cardiovascular condition
• New York Heart Association Class (NYHA) Class III or IV
• Uncontrolled hypertension despite medical therapy
• 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

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

Alaska Clinical Research Center, LLC

Anchorage, Alaska, United States

Countries

United States

Other Identifiers

C21003

Identifier Type: -

Identifier Source: org_study_id