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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01084655
First received: March 9, 2010
Last updated: July 1, 2013
Last verified: January 2013
  Purpose

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 ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetics (PK) of docetaxel and TAK-700 alone and in combination [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To obtain an estimate of prostate-specific antigen (PSA) response rates [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess time to prostate-specific antigen (PSA) progression and time to radiographic disease progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess measurable disease response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess changes in circulating tumor cell (CTC) counts [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084655

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

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01084655     History of Changes
Other Study ID Numbers: C21003
Study First Received: March 9, 2010
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 30, 2014