Clinical Trial: AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Metastat
Brief 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.
Detailed Summary:
Sponsor: Amgen
Current Primary Outcome: Progression Free Survival [ Time Frame: 2 3/4 years ]
Original Primary Outcome:
Current Secondary Outcome:
- Objective response rate (ORR) [ Time Frame: 2 3/4 years ]
- Duration of response (DOR) [ Time Frame: 2 3/4 years ]
- Change in continuous measures of tumor burden [ Time Frame: 2 3/4 years ]
- Time-adjusted area under the curve (AUC) for the FACT-Kidney Cancer Symptom Index (FKSI-15) scale score from baseline through disease progression with imputation for missing data [ Time Frame: 2 3/4 years ]
- Incidence of AEs and significant laboratory changes [ Time Frame: 2 3/4 years ]
- Incidence of the occurrence of anti-AMG 386 antibody formation [ Time Frame: 2 3/4 years ]
Original Secondary Outcome:
Information By: Amgen
Dates:
Date Received: April 26, 2007
Date Started: May 2007
Date Completion:
Last Updated: February 23, 2016
Last Verified: February 2016
