NCT01390519

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

4.5 years

First QC Date

June 30, 2011

Last Update Submit

January 12, 2016

Conditions

Metastatic Renal Cell Carcinoma (mRCC)

Keywords

mRCC,observational,Afinitor,everolimus,2.line

Outcome Measures

Primary Outcomes (1)

  • Time to progression (TTP)

    maximum of 12 months after inclusion of the last patient

Secondary Outcomes (3)

  • Treatment algorithm

    at end of study

  • Quality of life (QoL)(EORTC-QLQ C30)

    maximum of 12 months after inclusion of the last patient

  • Tolerability

    maximum of 12 months after inclusion of the last patient

Study Arms (1)

Afinitor

Afinitor

Other: everolimis

Interventions

everolimisOTHER
Also known as: RAD001
Afinitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced renal cell cancer whose disease has progressed on or after one VEGF-TKI therapy

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Kristiansand, 4615, Norway

Location

Novartis Investigative Site

Tromsø, 9038, Norway

Location

Novartis Investigative Site

Trondheim, 7006, Norway

Location

Biospecimen

Retention: NONE RETAINED

None Retained

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Everolimus

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 11, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

NO(3)