Status:
TERMINATED
Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Conditions:
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well orteronel works in treating patients with metastatic hormone-resistant prostate cancer. Orteronel may stop the growth of tumor cells by blocking some of the enzyme...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the relationship between circulating tumor cell (CTC)-based androgen receptor (AR) expression level and \>=-50% prostate-specific antigen (PSA) decline following 12 w...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Patients, even if surgically sterilized (i.e., status post vasectomy), 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 intercourse
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be =\< 2.5 x the upper limit of normal (ULN)
- Total bilirubin =\< 1.5 x ULN
- Estimated creatinine clearance using the Cockcroft-Gault formula must be \> 40 mL/minute
- Absolute neutrophil count (ANC) \>= 1500 cells/microliter
- Platelet count \>= 100,000 cells/microliter
- Testosterone \< 50 ng/dL
- Screening calculated ejection fraction of \>= 50% by multiple gated acquisition (MUGA) scan or echocardiogram; metastatic progression on primary androgen-deprivation therapy (medical or surgical castration)
- Progression requiring a change in oncologic therapy defined by any of the following:
- Radiographic progression: appearance or increase in measurable lesions on cross-sectional imaging or appearance of one or more new lesions on bone scan \* Rising PSA (\>= 2 ng/ml) which has risen on two occasions \>= 1 week apart
- Clinical progression evidenced by increased pain or other cancer-related symptoms
- Patients should have recovered from prior oncologic therapies to a Common Terminology Criteria (CTC) grade =\< 1 except stable neuropathy or alopecia at National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =\< 2; if rapid clinical progression is documented by imaging, changes in PSA, or symptoms, then study treatment can begin \>= 2 weeks from prior therapy; otherwise, the following time periods between prior anti-cancer therapies and study treatment day 1 will apply:
- \>= 3 weeks for prior cytotoxic therapies
- \>= 4 weeks for flutamide or nilutamide
- \>= 6 weeks for bicalutamide
- \>= 6 weeks since bone targeted radiopharmaceutical (e.g. samarium-153, radium-223)
- Gonadotropin-releasing hormone (GnRH) agonists (leuprolide acetate, goserelin, etc.) or antagonists (degarelix, etc.) should be continued in patients without surgically-induced castrate androgen levels
- For chemotherapy naïve castration-resistant prostate cancer who are moderately symptomatic or who have hepatic metastasis: subjects must not be a candidate for docetaxel-based chemotherapy.
Exclusion
- History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade \> 2 (NCI CTCAE, version 4), thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g. pericardial effusion, restrictive cardiomyopathy) within 6 months prior to first dose of study drug; chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
- New York Heart Association class III or IV heart failure
- Electrocardiogram (ECG) abnormalities of:
- Q-wave infarction, unless identified 6 or more months prior to screening
- Corrected QT (QTc) interval \> 460 msec
- Patient has received other investigational drugs within 28 days before enrollment
- Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy
- Known hypersensitivity to compounds related to TAK-700 or to TAK-700 excipients
- Uncontrolled hypertension despite appropriate medical therapy (blood pressure \[BP\] of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening visit); Note: patients may be rescreened after adjustment of antihypertensive medications
- Known active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study
- Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing tablets
- Prior treatment with \>= 3 lines of cytotoxic chemotherapy for metastatic prostate cancer
- Prior treatment with TAK-700
Key Trial Info
Start Date :
October 25 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01866423
Start Date
October 25 2013
End Date
July 26 2016
Last Update
August 31 2017
Active Locations (1)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033