Safety Study of TAK-700 in Subjects With Prostate Cancer. (TAK-700)

March 4, 2016 updated by: Millennium Pharmaceuticals, Inc.

A Phase 1/2, Open-Label, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Metastatic, Androgen-Independent Prostate Cancer Subjects

The purpose of this study is to determine the safety and tolerability of TAK-700 in patients with asymptomatic metastatic, androgen independent prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States
        • USC Westside Prostate Cancer Center
      • Los Angeles, California, United States
        • USC Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90048
        • University of Southern California
      • Los Angeles, California, United States
        • The Angeles Clinic and Research Institute
    • Florida
      • Aventura, Florida, United States
        • South Florida Medical Research
      • Fort Myers, Florida, United States
        • Florida Cancer Specialists
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical Center
      • Chicago, Illinois, United States
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States
        • University of Chicago Pharmacy
      • Evanston, Illinois, United States
        • Evanston Hospital
      • Evanston, Illinois, United States
        • NorthShore University HealthSystem
      • Evanston, Illinois, United States
        • Kellogg Pharmacy - Evanston Hospital
      • Glenview, Illinois, United States
        • Kellogg Cancer Care Center
    • New York
      • East Syracuse, New York, United States
        • Hematology/Oncology Associates of Central New York
    • Ohio
      • Canton, Ohio, United States
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States
        • Taussig Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States
        • Tennessee Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subject is male and at least 18 years of age.
  • Subject has histologically- or cytologically-confirmed prostate adenocarcinoma with metastatic, progressive disease while on androgen deprivation therapy.
  • Subject has radiograph-documented (computed tomography, magnetic resonance imaging or x-ray) metastatic disease.
  • Subject has undergone orchiectomy or is expected to continue receiving luteinizing hormone-releasing hormone analogue therapy, and has a testosterone level of <50 ng/dL at screening.
  • Subject has discontinued all antiandrogen therapy (within 30 days for flutamide and within 6 weeks for all others) prior to their first dose of study drug.
  • Subject has a prostate-specific antigen level ≥5 ng/mL.
  • Subject meets all screening laboratory values as specified in the protocol.
  • Subject has a screening ejection fraction that is above the lower limit of the institutional normal range.
  • Subject has ECOG performance status of 0 to 2.
  • Subject has normal or, in the opinion of the investigator, clinically insignificant, physical examination findings, ECG and chest x-ray results.
  • Subjects, even if surgically sterilized (ie, status postvasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.

Exclusion Criteria:

  • Subject has known hypersensitivity to TAK-700 or related compounds.
  • Subject has received prior therapy with aminoglutethimide or ketoconazole within 30 days prior to the first dose of study drug.
  • Subject has received prior chemotherapy for prostate cancer.
  • Subject has received any investigational compound within 30 days prior to first dose of study drug.
  • Subject has received prior herbal product known to decrease prostate-specific antigen levels (eg, Saw Palmetto, PC-SPES) within 30 days prior to the first dose of study drug.
  • Subject has received radiation therapy for prostate cancer within 30 days prior to first dose of study drug.
  • Chronic therapy with oral or other systemically administered corticosteroids, such as prednisone, within 30 days prior to Screening. Chronic therapy is defined as the use of corticosteroids for more than 7 days within a 30-day period.
  • Subject has current spinal cord compression, current bilateral hydronephrosis, or current bladder neck outlet obstruction.
  • Subject has a history of adrenal insufficiency.
  • Subject has a history of myocardial infarction, ischaemic symptomatic heart disease, cardiac arrhythmias or thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 12 months prior to first dose of study drug.
  • Subject has any symptoms which the investigator deems related to prostate cancer, i.e., bone pain, pelvic pain.
  • Subject has a history of congestive heart failure (New York Heart Association Class II or greater.
  • Subject has history of another malignancy other than basal cell carcinoma or state 1 squamous cell carcinoma of the skin, within the last 5 years.
  • Subject has uncontrolled hypertension.
  • Subject is known to have HIV infection, chronic Hepatitis B or C or any other serious medical condition or psychiatric illness that might affect life expectancy or make it difficult to successfully manage and follow the subject according to protocol.
  • Subject is unable to understand verbal or written English or any other language for which a certified translation of the institutional review board (IRB)-approved informed consent has been provided.
  • Subject is unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (TAK-700)
Drug: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning
Experimental: Arm 2 (TAK-700 at 400 mg & 5 mg prednisone)
Drug: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning
Experimental: Arm 3 (TAK-700 at 600 mg & 5 mg prednisone)
Drug: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning
Experimental: Arm 4 (TAK-700 at 600 mg)
Drug: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of TAK-700 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
Time Frame: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy and pharmacokinetics (PSA response and/or objective disease response)
Time Frame: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimate)

December 6, 2007

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-700_201
  • TAK-700-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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