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A Trial With Vinflunine in Patients With Metastatic Bladder Cancer and Impaired Renal Function

NCT02665039 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-10-08

No results posted yet for this study

Summary

This study aim to compare the efficacy, safety and quality of life of vinflunine/gemcitabine and carboplatin/gemcitabine in patients with metastatic urothelial cancer and impaired renal function.

Conditions

Interventions

DRUG

Vinflunine

Vinflunine will be given intravenously once every 21 days, starting at a dose of: * 280 mg/m2 in patients with GFR 40-60 ml/min * 250 mg/m2 in patients aged \>80 years and/or GFR 30-40 ml/min

DRUG

Gemcitabine

Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2

DRUG

Carboplatin

Carboplatin will be given intravenously once every 21 days, starting at a dose of AUC 4.5

Sponsors & Collaborators

  • Dr Anders Ullén

    lead OTHER

Principal Investigators

  • Anders Ullén, M.D., Ph.D. · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Denmark
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02665039 on ClinicalTrials.gov