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Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients

NCT01599754 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 724

Last updated 2019-09-20

Study results available
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Summary

The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.

Conditions

  • Clear Cell Renal Carcinoma

Interventions

DRUG

Axitinib

Axitinib 5 mg twice daily

DRUG

Placebo

Placebo twice daily

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • SFJ Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • SFJ Pharma Ltd. II

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2017-10-10
Completion
2018-05-31

Countries

  • United States
  • China
  • France
  • Hong Kong
  • India
  • Japan
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT01599754 on ClinicalTrials.gov