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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C21001

NCT ID:

NCT01046916

Start Date:

May 2010

Completion Date:

February 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Oregon Health and Sciences UniversityPortland, Oregon  
University of Wisconsin Hospitals and ClinicsMadison, Wisconsin  53792