MedTrace Logo

Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma

NCT02689167 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2021-11-29

No results posted yet for this study

Summary

Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be offered participation in this study during the consultation as part of their usual care. The patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks "on " alternating with 2 weeks "off "

As soon as a dose or schedule adjustment is required, regardless of cause, the patient will be randomised 1/1:

* Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in accordance with the Marketing Authorisation); 4 weeks "on " alternating with 2 weeks "off "
* Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen (investigational arm); 2 weeks "on " alternating with 1 week "off "

Conditions

  • Kidney Neoplasms
  • Metastatic Renal Cell Cancer

Interventions

DRUG

Sunitinib

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • antoine thiery-vuillemin, MD PhD · Centre Hospitalier Universitaire de Besancon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-19
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02689167 on ClinicalTrials.gov