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Third Line TKI After 2 TKIs in Patients With mRCC (Tokio Study)

NCT03456401 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-03-07

No results posted yet for this study

Summary

The study aims to evaluate the efficacy of a third TKI after two previous lines of therapy with TKIs, in terms of median progression free survival (mPFS), in patients affected by metastatic renal cancer cell.

Patients receiving the sequence Sunitinib- Axitinib, will receive Sorafenib.

Patients receiving the sequence Pazopanib-Sorafenib, will receive Sunitinib.

Sorafenib dosage 400mg orally, twice a day.

Sunitinib dosage 50 mg 4 weeks on followed by 2 weeks a rest.

The therapy will be continued until disease progression or unacceptable toxicity.

Conditions

  • Renal Cancer Cell

Interventions

DRUG

Sorafenib or Sunitinib

After two lines of TKIs, patients received a third line with sunitinib or sorafenib, according to previous treatments

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Giuseppe Procopio, MD · IRCCS Istituto Nazionale Tumori

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-11-08
Completion
2017-11-08

Countries

  • Italy

Study Locations

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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 NCT03456401 on ClinicalTrials.gov