Trials / Completed
CompletedNCT00770848
AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 162 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 102 | Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W. |
| DRUG | AMG 102 | Investigational product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment, will be administered by IV Q3W. |
| DRUG | Mitoxantrone | Administered Q3W for a maximum of 12 cyles |
| DRUG | Placebo | Placebo |
| DRUG | Prednisone | 5 mg orally BID |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2011-01-01
- Completion
- 2012-04-01
- First posted
- 2008-10-10
- Last updated
- 2014-03-10
Source: ClinicalTrials.gov record NCT00770848. Inclusion in this directory is not an endorsement.