Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Stopped early · Phase 2

Conditions studied: Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

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 enzymes needed for cell growth.

Key facts

Study ID

NCT01866423

Run by

University of Southern California

People needed

4

Starts

2013-10-25

Expected to finish

2016-07-26

Last updated by the study team

2017-08-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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.

You may not qualify if…

• 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

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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