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Clinical Trials/NCT01562197
NCT01562197
Completed
Phase 2

A Randomized Phase II Clinical Trial on the Efficacy of Axitinib as a Monotherapy or in Combination With Lomustine for the Treatment of Patients With Recurrent Glioblastoma

Bart Neyns1 site in 1 country56 target enrollmentApril 2014

Overview

Phase
Phase 2
Intervention
axitinib
Conditions
Glioblastoma Multiforme
Sponsor
Bart Neyns
Enrollment
56
Locations
1
Primary Endpoint
anti-tumor effect of axitinib as a single therapeutic agent and in combination with Lomustine
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This clinical trial will recruit patients diagnosed with glioblastoma at the time of recurrence or progression following prior treatment with surgery, radiation therapy and alkylating chemotherapy. Patients will be screened and if found eligible will be randomized to one of two treatment arms (1:1 randomization). Patients randomized to the Axitinib treatment-arm will be treated with Axitinib until progression (they can be treated after progression in the Axitinib plus lomustine arm), unacceptable treatment related toxicity, or patients refusal to continue study treatment. Patients randomized to the Axitinib plus Lomustine-arm will receive treatment until progression, unacceptable treatment related toxicity, or patients refusal to continue study treatment.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bart Neyns
Responsible Party
Sponsor Investigator
Principal Investigator

Bart Neyns

MD PhD

Universitair Ziekenhuis Brussel

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Axitinib

axitinib treatment arm

Intervention: axitinib

Axitinib plus Lomustine

Axitinib plus Lomustine

Intervention: Axitinib plus Lomustine

Outcomes

Primary Outcomes

anti-tumor effect of axitinib as a single therapeutic agent and in combination with Lomustine

Time Frame: 6months

To estimate the anti-tumor effect of axitinib as a single therapeutic agent for the treatment of glioblastoma patients at the time of recurrence/progression following prior surgery, radiation and alkylating chemotherapy and in combination with Lomustine

Study Sites (1)

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