Clinical trial · Interventional
Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Phase 2 Trial of TAK-700 (Also Known as Orteronel) Without Prednisone for Metastatic Castration-Resistant Prostate Cancer
NCT01866423CI-TRIAL-00029375terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not progressing toward scientific goals
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Hormone-resistant Prostate Cancer | — | UNRESOLVED | — |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| orteronel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (orteronel)
- description
- Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: orteronel
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Androgen Receptor (AR) Protein Expression Levels in CTCs
- timeFrame
- Up to 4 weeks
- description
- The two-sample t-test will be used. Once association between AR protein expression levels and response is established, graphical methods such as receiver-operator curves (ROC) or more quantitative methods such as the maximal chi-square method to determine whether there might be a cut-point with either great sensitivity or great specificity (or both) for identifying a cohort with either a high or low likelihood of prostate-specific antigen (PSA) response.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.