A Norwegian Observational Trial Evaluating the Treatment of Advanced Renal Cell Cancer Patients Under Treatment of Afinitor

NCT ID: NCT01390519

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-12-31

Brief Summary

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This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.

Detailed Description

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Conditions

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Metastatic Renal Cell Carcinoma (mRCC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Afinitor

Afinitor

everolimis

Intervention Type OTHER

Interventions

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everolimis

Intervention Type OTHER

Other Intervention Names

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RAD001

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Confirmed diagnosis of advanced renal cell cancer
* Progression on or after one VEGF -TKI (e.g. sunitibin, sorafenib)
* Written informed consent

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Kristiansand, , Norway

Site Status

Novartis Investigative Site

Tromsø, , Norway

Site Status

Novartis Investigative Site

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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CRAD001LNO03

Identifier Type: -

Identifier Source: org_study_id

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