Safety Study of TAK-700 in Subjects With Prostate Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00569153
First received: December 4, 2007
Last updated: July 1, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine the safety and tolerability of TAK-700 in patients with asymptomatic metastatic, androgen independent prostate cancer.


Condition Intervention Phase
Prostatic Neoplasms
Drug: TAK-700
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Metastatic, Androgen-Independent Prostate Cancer Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and tolerability of TAK-700 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests. [ Time Frame: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy and pharmacokinetics (PSA response and/or objective disease response) [ Time Frame: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter. ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: April 2008
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 (TAK-700) Drug: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning
Experimental: Arm 2 (TAK-700 at 400 mg & 5 mg prednisone) Drug: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning
Experimental: Arm 3 (TAK-700 at 600 mg & 5 mg prednisone) Drug: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning
Experimental: Arm 4 (TAK-700 at 600 mg) Drug: TAK-700

Phase 1 portion of study:

TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

Phase 2 portion of study:

Patients will receive one of 4 treatments:

  • TAK-700 at 300 mg twice/day
  • TAK-700 at 400 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg and 5 mg prednisone twice/day
  • TAK-700 at 600 mg once/day in the morning

  Eligibility

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

Inclusion Criteria:

  • Subject is male and at least 18 years of age.
  • Subject has histologically- or cytologically-confirmed prostate adenocarcinoma with metastatic, progressive disease while on androgen deprivation therapy.
  • Subject has radiograph-documented (computed tomography, magnetic resonance imaging or x-ray) metastatic disease.
  • Subject has undergone orchiectomy or is expected to continue receiving luteinizing hormone-releasing hormone analogue therapy, and has a testosterone level of <50 ng/dL at screening.
  • Subject has discontinued all antiandrogen therapy (within 30 days for flutamide and within 6 weeks for all others) prior to their first dose of study drug.
  • Subject has a prostate-specific antigen level ≥5 ng/mL.
  • Subject meets all screening laboratory values as specified in the protocol.
  • Subject has a screening ejection fraction that is above the lower limit of the institutional normal range.
  • Subject has ECOG performance status of 0 to 2.
  • Subject has normal or, in the opinion of the investigator, clinically insignificant, physical examination findings, ECG and chest x-ray results.
  • Subjects, even if surgically sterilized (ie, status postvasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.

Exclusion Criteria:

  • Subject has known hypersensitivity to TAK-700 or related compounds.
  • Subject has received prior therapy with aminoglutethimide or ketoconazole within 30 days prior to the first dose of study drug.
  • Subject has received prior chemotherapy for prostate cancer.
  • Subject has received any investigational compound within 30 days prior to first dose of study drug.
  • Subject has received prior herbal product known to decrease prostate-specific antigen levels (eg, Saw Palmetto, PC-SPES) within 30 days prior to the first dose of study drug.
  • Subject has received radiation therapy for prostate cancer within 30 days prior to first dose of study drug.
  • Chronic therapy with oral or other systemically administered corticosteroids, such as prednisone, within 30 days prior to Screening. Chronic therapy is defined as the use of corticosteroids for more than 7 days within a 30-day period.
  • Subject has current spinal cord compression, current bilateral hydronephrosis, or current bladder neck outlet obstruction.
  • Subject has a history of adrenal insufficiency.
  • Subject has a history of myocardial infarction, ischaemic symptomatic heart disease, cardiac arrhythmias or thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 12 months prior to first dose of study drug.
  • Subject has any symptoms which the investigator deems related to prostate cancer, i.e., bone pain, pelvic pain.
  • Subject has a history of congestive heart failure (New York Heart Association Class II or greater.
  • Subject has history of another malignancy other than basal cell carcinoma or state 1 squamous cell carcinoma of the skin, within the last 5 years.
  • Subject has uncontrolled hypertension.
  • Subject is known to have HIV infection, chronic Hepatitis B or C or any other serious medical condition or psychiatric illness that might affect life expectancy or make it difficult to successfully manage and follow the subject according to protocol.
  • Subject is unable to understand verbal or written English or any other language for which a certified translation of the institutional review board (IRB)-approved informed consent has been provided.
  • Subject is unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.
  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: NCT00569153

Locations
United States, California
USC Westside Prostate Cancer Center
Beverly Hills, California, United States
University of Southern California
Los Angeles, California, United States, 90048
The Angeles Clinic and Research Institute
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
United States, Florida
South Florida Medical Research
Aventura, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern University Medical Center
Chicago, Illinois, United States, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
University of Chicago Pharmacy
Chicago, Illinois, United States
Kellogg Pharmacy - Evanston Hospital
Evanston, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Kellogg Cancer Care Center
Glenview, Illinois, United States
United States, New York
Hematology/Oncology Associates of Central New York
East Syracuse, New York, United States
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Taussig Cancer Institute
Cleveland, Ohio, United States
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States
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: NCT00569153     History of Changes
Other Study ID Numbers: TAK-700_201, TAK-700-201
Study First Received: December 4, 2007
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:
Androgen-independent prostate cancer, metastatic

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014