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AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib

NCT00467025 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2016-03-23

No results posted yet for this study

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

  • Advanced Renal Cell Carcinoma

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-04-30
Completion
2014-06-30

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00467025 on ClinicalTrials.gov