drugset / Trial / NCT00859781
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Phase 2
Active not recruiting
55 enrolled
Weill Medical College of Cornell University
United States Department of Defense · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.
Timeline
- Start
- 2009-06
- Primary completion
- 2022-02-10
- Completion
- 2026-09
Outcome
Missed primary endpoint
registry analysis (superiority test); 1. 177Lu-J591+Ketoconzole vs 2. 111In-J591 + Ketoconazole; p = 0.08; NCT00859781 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | J591 177LU | Monoclonal antibody | 70 unknown | — |
| Background | Hydrocortisone | Other / unclassified | 10 mg | Oral |
| Background | Hydrocortisone | Other / unclassified | 20 mg | Oral |
| Background | Ketoconazole | Small molecule | 400 mg | Oral |