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Study Complete
Sponsor ID
20060159

AMG 386, 20060159 Phase 2, RCC 1st Line in combination with Sorafenib

Sponsor ID
20060159
Clinicaltrials.gov ID
NCT00467025
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
AMG 386
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
152
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression Free Survival

Timeframe: 2 3/4 years

Secondary Outcome Measures

Objective response rate (ORR)

Timeframe: 2 3/4 years

Duration of response (DOR)

Timeframe: 2 3/4 years

Change in continuous measures of tumor burden

Timeframe: 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

Timeframe: 2 3/4 years

Incidence of AEs and significant laboratory changes

Timeframe: 2 3/4 years

Incidence of the occurrence of anti-AMG 386 antibody formation

Timeframe: 2 3/4 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Kidney Cancer
    • Sex
    All
    Trial Dates
    May 2007 - Apr 2010
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Subjects must have a histologically confirmed metastatic RCC with a clear cell component • Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification. • Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications • Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening. • ECOG of 0 or 1
    Exclusion Criteria:
    Disease Related • Known history of central nervous system metastases. • Previous treatment (excluding surgery and palliative radiotherapy) for advanced or metastatic renal cell carcinoma • Focal radiation therapy for palliation of pain from bony metastases within 14 days of randomization. Medications • Currently or previously treated with inhibitors of VEGF. • Currently or previously treated with inhibitors of angiopoietin or Tie2. • Currently or previously treated with bevacizumab. General Medical • Diagnosis of acute pancreatitis. • Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, grade 2 or greater peripheral vascular disease, arrhythmias not controlled by outpatient medication, or unstable angina within 1 year prior to randomization • Major surgery within 30 days before randomization or still recovering from prior surgery • Uncontrolled hypertension as defined as diastolic > 90 mmHg OR systolic >150 mmHg. Anti-hypertensive medications are permitted. Other • Other investigational procedures are excluded • Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)