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

This study has been completed.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc. Identifier:
First received: March 9, 2010
Last updated: March 4, 2016
Last verified: March 2016
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).

Condition Intervention Phase
Prostate Cancer Drug: TAK-700 Drug: Docetaxel Drug: Prednisone Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Phase 1/2 Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To confirm the maximum dose of TAK-700 that can be safely administered in combination with docetaxel and prednisone [ Time Frame: 3 years ]
  • To characterize the pharmacokinetics (PK) of docetaxel and TAK-700 alone and in combination [ Time Frame: 3 years ]
  • To obtain an estimate of prostate-specific antigen (PSA) response rates [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • To assess time to prostate-specific antigen (PSA) progression and time to radiographic disease progression [ Time Frame: 3 years ]
  • To assess measurable disease response [ Time Frame: 3 years ]
  • To assess changes in circulating tumor cell (CTC) counts [ Time Frame: 3 years ]

Enrollment: 38
Study Start Date: July 2010
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-700 with docetaxel and prednisone Drug: TAK-700
TAK-700 with docetaxel and prednisone on a continuous schedule.
Drug: Docetaxel
TAK-700 with docetaxel and prednisone on a continuous schedule.
Drug: Prednisone
TAK-700 with docetaxel and prednisone on a continuous schedule.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 study:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01084655

United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT01084655     History of Changes
Other Study ID Numbers: C21003
Study First Received: March 9, 2010
Last Updated: March 4, 2016

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal processed this record on August 16, 2017