NCT03846128

Brief Summary

Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer. Collection of additional blood tubes during routine blood tests for patient follow-up, to evaluate the plasma concentration of Sunitinib and its active metabolite desethyl-Sunitinib (DES)

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

January 31, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 3, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

January 31, 2019

Last Update Submit

April 8, 2026

Conditions

Metastatic Kidney Cancer

Outcome Measures

Primary Outcomes (12)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    At the end of Cycle 1 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    At the end of Cycle 2 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    At the end of Cycle 3 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    At the end of Cycle 4 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    At the end of Cycle 5 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib

    At the end of Cycle 6 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    At the end of Cycle 1 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    At the end of Cycle 2 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    At the end of Cycle 3 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    At the end of Cycle 4 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    At the end of Cycle 5 (each cycle is 28 days)

  • hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

    At the end of Cycle 6 (each cycle is 28 days)

Secondary Outcomes (10)

  • plasma desethyl-Sunitinib (DES) concentration

    Cycle1 Day14 (each cycle is 28 days)

  • plasma Sunitinib concentration

    Cycle1 Day14 (each cycle is 28 days)

  • plasma Sunitinib concentration

    Cycle1 Day28 (each cycle is 28 days)

  • plasma DES concentration

    Cycle1 Day28 (each cycle is 28 days)

  • plasma Sunitinib concentration

    Cycle2 Day28(each cycle is 28 days)

  • +5 more secondary outcomes

Interventions

blood sampleBIOLOGICAL

blood sample performed on C1D1, C1D14, C2D1, C3D1 and C6D1

Eligibility Criteria

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

Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer

You may qualify if:

  • Patient at least 18 years old
  • Patient who read and understood the newsletter and signed the consent form
  • Renal cell carcinoma histologically proven stage IV
  • Metastatic stage proven on CT, synchronous or metachronous examination
  • Patient operated on or not from the primary tumor
  • Eligible for first-line systemic therapy with Sunitinib-targeted therapy for oncology urology
  • Affiliation to a social security scheme
  • General condition WHO 0 to 2
  • Life expectancy estimated at more than 6 months at baseline

You may not qualify if:

  • Non-metastatic disease
  • Other cancer proven histologically, or in complete remission for less than 2 years
  • Contraindication to SUTENT 50 mg hard capsules: Hypersensitivity to the active substance or to any of the excipients
  • History of immunotherapy treatment for kidney cancer, previous treatment with targeted therapies for the same or previous cancer
  • Pregnant or lactating woman or wishing to breastfeed within 6 months after the last treatment or no known contraception,
  • Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-guardianship or curatorship
  • Patient currently involved in an interventional trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de ROUEN

Rouen, 76031, France

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 19, 2019

Study Start

June 3, 2019

Primary Completion

October 8, 2021

Study Completion

October 8, 2021

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

FR(1)