drugset / Trial / NCT00770848
AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objectives of this study are the following: Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC)
Timeline
- Start
- 2008-11
- Primary completion
- 2011-01
- Completion
- 2012-04
Publications
- Background Oliner K.BM Ph2 CRPC.Journal-004521;
- Background Ryan CJ, Rosenthal M, Ng S, Alumkal J, Picus J, Gravis G, Fizazi K, Forget F, Machiels JP, Srinivas S, Zhu M, Tang R, Oliner KS, Jiang Y, Loh E, Dubey S, Gerritsen WR. Targeted MET inhibition in castration-resistant prostate cancer: a randomized phase II study and biomarker analysis with rilotumumab plus mitoxantrone and prednisone. Clin Cancer Res. 2013 Jan 1;19(1):215-24. doi: 10.1158/1078-0432.CCR-12-2605. Epub 2012 Nov 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rilotumumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Rilotumumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Rilotumumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Mitoxantrone | Small molecule | — | — |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |