NCT03129724

Brief Summary

Describe in patients with metastatic kidney cancer treatment modalities with the type sequences: TKI - mTORi - Axitinib or VEGF mAb - mTORi - Axitinib.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

July 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 26, 2017

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

July 5, 2016

Last Update Submit

April 21, 2017

Conditions

Keywords

Kidney NeoplasmsKidneyNeoplasmsTKIAxitinibVEGFmTORi

Outcome Measures

Primary Outcomes (1)

  • Evolution of Kidney cancer

    after surgery, up to 1 year]

Eligibility Criteria

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

Patient with metastatic kidney cancer (all histological types) Patient has been treated or under treatment with axitinib (Inlyta®) in the third line after the first line of targeted TKI therapy and after mTORi in 2nd line, or Patient receiving the treatment sequence VEGFmAb - mTORi - axitinib

You may qualify if:

  • Patient with metastatic kidney cancer (all histological types)
  • Male or female aged (e) of 18 or more
  • Patient has been treated or under treatment with axitinib (Inlyta®) in the third line after the first line of targeted TKI therapy and after mTORi in 2nd line, or
  • Patient receiving the treatment sequence VEGFmAb - mTORi - axitinib For living patients: patient informed and having given oral consent

You may not qualify if:

  • Patient who received more than one line of antiangiogenic therapy in the metastatic phase before initiation of treatment with axitinib (except patients in the study Pisces) Patient received a second line treatment with TKI Patient refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

April 26, 2017

Study Start

September 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

April 26, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share