Trials / Terminated
TerminatedNCT01866423
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 enzymes needed for cell growth.
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 weeks of therapy with TAK-700 (orteronel). SECONDARY OBJECTIVES: I. To assess changes in PSA and CTC levels and time to PSA progression (best response, decline at 12 weeks as continuous variable, etc.) with or without prior docetaxel-based treatment. II. To assess measurable disease response and time to radiographic disease progression for castration-resistant prostate cancer (CRPC) with or without prior docetaxel-based treatment. III. To explore relationships between endocrine and clinical responses. IV. To confirm the safety of TAK-700 administered without prednisone in patients with metastatic CRPC. OUTLINE: Patients receive orteronel orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Conditions
- Adenocarcinoma of the Prostate
- Hormone-resistant Prostate Cancer
- Recurrent Prostate Cancer
- Stage IV Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | orteronel | Given PO |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2013-10-25
- Primary completion
- 2015-07-23
- Completion
- 2016-07-26
- First posted
- 2013-05-31
- Last updated
- 2017-08-31
- Results posted
- 2017-08-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01866423. Inclusion in this directory is not an endorsement.