Trials / Active Not Recruiting
Active Not RecruitingNCT02452008
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Overcoming Drug Resistance in Metastatic Castration-resistant Prostate Cancer With Novel Combination of TGF-β Receptor Inhibitor LY2157299 and Enzalutamide: a Randomized Multi-site Phase II Study
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
- Sex
- Male
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to compare the progression free survival (PFS) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enzalutamide | 160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle. |
| DRUG | LY2157299 | 150 mg of LY2157299 is administered orally twice a day on days 1-14 of each cycle. |
Timeline
- Start date
- 2016-05-03
- Primary completion
- 2025-12-08
- Completion
- 2026-12-01
- First posted
- 2015-05-22
- Last updated
- 2025-12-19
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02452008. Inclusion in this directory is not an endorsement.