Trials / Completed
CompletedNCT00467025
AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination With AMG 386 or Placebo In Subjects With Metastatic Clear Cell Carcinoma of the Kidney
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 386 | 3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression |
| DRUG | Sorafenib | 400 mg PO BID |
| DRUG | AMG 386 placebo IV | AMG 386 placebo IV |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2010-04-01
- Completion
- 2014-06-01
- First posted
- 2007-04-27
- Last updated
- 2016-03-23
Source: ClinicalTrials.gov record NCT00467025. Inclusion in this directory is not an endorsement.