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Dovitinib in BCG Refractory Urothelial Carcinoma With FGFR3 Mutations or Over-expression

NCT01732107 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-07-11

Study results available
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Summary

This trial will assess the 6-month complete response rate and toxicity profile of oral dovitinib therapy in BCG-refractory urothelial carcinoma patients with tumors with FGFR3 mutations or over-expression who are ineligible for or refusing cystectomy.

Conditions

Interventions

DRUG

Dovitinib

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Sponsors & Collaborators

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Noah Hahn, M.D.

    lead OTHER

Principal Investigators

  • Noah Hahn, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2017-03-06
Completion
2017-03-06

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT01732107 on ClinicalTrials.gov