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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01084655
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : April 4, 2016
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: TAK-700 Drug: Docetaxel Drug: Prednisone Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT01084655     History of Changes
Other Study ID Numbers: C21003
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 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