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Safety Study of TAK-700 in Subjects With Prostate Cancer.
This study is currently recruiting participants.
Verified by Millennium Pharmaceuticals, Inc., March 2009
First Received: December 4, 2007   Last Updated: March 31, 2009   History of Changes
Sponsored by: Millennium Pharmaceuticals, Inc.
Information provided by: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00569153
  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 I
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

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: 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 of maximum tolerated dose. [ Time Frame: Time Frame: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter. ] [ Designated as safety issue: No ]

Estimated Enrollment: 61
Study Start Date: April 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: TAK-700
TAK-700 100 mg, 200 mg, 300 mg, 400 mg and 600mg (dose escalation), tablets, orally, twice daily until disease progression or occurrence of an unacceptable adverse event.

  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 4 weeks 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 has clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory, unless the results are deemed not clinically significant by the investigator or sponsor.
  • 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 an absolute neutrophil count ≥1500/uL, a platelet count ≥100,000/uL and hemoglobin ≥10g/dL.
  • Subject has a serum aspartate aminotransferase levels ≤ 1.5 times the institutional upper limit of normal, and bilirubin levels ≤ 1.5 times the institutional upper limit of normal;
  • Subject has cardiac enzyme results (CK-MB and troponins I&T) within the reference ranges for the testing laboratory.
  • Subject has normal or, in the opinion of the investigator, clinically insignificant, physical examination findings, ECG and chest x-ray results.

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 has a serious medical condition or psychiatric illness that might affect life expectancy or make it difficult to successfully manage and follow the subject.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569153

Contacts
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-866-835-2233 medical@mlnm.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Northwestern University Medical Center Recruiting
Chicago, Illinois, United States, 60611
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc. ( Clinical Research Monitor )
Study ID Numbers: TAK-700_201, TAK-700-201
Study First Received: December 4, 2007
Last Updated: March 31, 2009
ClinicalTrials.gov Identifier: NCT00569153     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009