Bevacizumab in Metastatic Renal Cancer

NCT ID: NCT02627144

Last Updated: 2016-08-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-09-30

Brief Summary

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This is a non-interventional, multicenter study to evaluate efficacy and safety of intravenous bevacizumab (Avastin) in combination with interferon alpha-2a immunotherapy for first-line treatment in participants with advanced and/or metastatic renal cell cancer (mRCC) in daily routine.

Detailed Description

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Conditions

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Renal Cell Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Advanced and/or Metastatic RCC participants

Participants with mRCC who are being treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression will be observed. No diagnostic or therapeutic interventions will be given other than used in normal daily routine.

Bevacizumab

Intervention Type DRUG

Bevacizumab will be administered at the recommended dose of 10 mg/kg of body weight once every 2 weeks as an intravenous infusion until disease progression.

Interferon alpha-2a

Intervention Type DRUG

Interferon alpha-2a will be administered at the recommended starting dose of 9 MIU 3 times a week until disease progression.

Interventions

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Bevacizumab

Bevacizumab will be administered at the recommended dose of 10 mg/kg of body weight once every 2 weeks as an intravenous infusion until disease progression.

Intervention Type DRUG

Interferon alpha-2a

Interferon alpha-2a will be administered at the recommended starting dose of 9 MIU 3 times a week until disease progression.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed advanced and/or metastatic renal cell cancer
* No contraindications for Avastin according to summary of product characteristics (SmPC)

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Freiburg im Breisgau, , Germany

Site Status

Countries

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Germany

References

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Schultze-Seemann W, Schulz H, Tschechne B, Hackl M. Bevacizumab plus IFN-alpha-2a in First-line Treatment of Patients With Advanced or Metastatic Renal Cell Carcinoma: A Prospective German Non-interventional Study. Anticancer Res. 2019 Feb;39(2):875-882. doi: 10.21873/anticanres.13188.

Reference Type DERIVED
PMID: 30711970 (View on PubMed)

Other Identifiers

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ML21519

Identifier Type: -

Identifier Source: org_study_id

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