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An Open-label Phase 1/2 Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

An Open-label Phase 1/2 Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria:

Each patient must meet all of the following 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

- Physical examination findings that are consistent with other study entry or exclusion
criteria and identified but not excluded chronic conditions

- 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

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the

- 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

Type of Study:


Study Design:

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

Outcome Measure:

To confirm the maximum dose of TAK-700 that can be safely administered in combination with docetaxel and prednisone

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

February 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Alaska Clinical Research Center, LLCAnchorage, Alaska  99508