Status:
TERMINATED
NaF Positron Emission Tomography/Computed Tomography (PET/CT)Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastasis
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Prostatic Neoplasms
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate treatment response in bone metastases in subjects with prostate cancer treated with the investigational drug, TA...
Eligibility Criteria
Inclusion
- Male patients 18 years or older
- Voluntary written consent
- Histologically proven adenocarcinoma of the prostate
- Evidence of radiographic bone metastases
- May have received prior chemotherapy for metastatic disease, but prior chemotherapy is not a requirement for eligibility
- Eastern Cooperative Oncology Group performance status 0-2
- Serum testosterone level is less than or equal to 50 ng/dL
- Has undergone orchiectomy or plan to continue receiving gonadotropin releasing hormone (GnRH) analogue therapy
- Adequate organ function as measured by screening laboratory values specified in the protocol
- Must agree to use appropriate contraceptives prior to study procedures, during duration of study participation and for 4 months after last dose of TAK 700
- Must be able to lie flat for greater than or equal to 30 minutes during PET/CT imaging
- Screening calculated ejection fraction of greater than or equal to 50% by multigated radionuclide angiography (MUGA) scan or Echocardiogram
Exclusion
- Received Strontium-89, Samarium-153, or other radioisotope within 3 months of registration
- history of allergic reactions attributed to compounds similar to sodium fluoride F-18 (NaF)
- history of seizure disorder
- Known history of brain metastases
- Concurrent treatment with any herbal products within 7 days of study entry
- Received radiotherapy less than or equal to 4 weeks prior to registration
- Known hypersensitivity to TAK-700 or related compounds
- Prior therapy for treatment of metastatic castrate resistant prostate cancer with any androgen biosynthesis inhibitor or androgen signaling pathway inhibitor such as: enzalutamide (MDV-3100), abiraterone, ketoconazole, or aminoglutethimide
- Current bladder neck outlet obstruction
- Current spinal cord compression
- Current bilateral hydronephrosis
- History of adrenal insufficiency
- History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias (over grade 2), thromboembolic events, or any other cardiac condition within 6 months prior to first dose of study drug.
- Uncontrolled high blood pressure
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
- Major surgery less than or equal to 4 weeks before the first dose of study drug
- Serious infection less than or equal to 2 weeks before the first dose of study drug
- Known gastrointestinal (GI) disease or GI procedure that could interfere with oral absorption or tolerance of TAK-700, including difficulty swallowing capsules
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01816048
Start Date
May 1 2013
End Date
November 1 2016
Last Update
December 9 2019
Active Locations (1)
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1
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792