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A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.

NCT00520403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-10-13

Study results available
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Summary

This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.

Conditions

  • Renal Cell Cancer

Interventions

DRUG

bevacizumab [Avastin]

15mg/kg iv every 3 weeks

DRUG

Interferon alfa-2a

3 MioIU sc escalating to 18 MioIU sc, 3 times weekly

DRUG

Vinblastine

0.1mg/kg iv every 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Germany

Study Locations

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Entities

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 NCT00520403 on ClinicalTrials.gov