NCT01562197

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Bart Neyns · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	axitinib	The starting dose of axitinib (AG-013736) is 5 mg BID administered orally with food.
DRUG	Axitinib plus Lomustine	Lomustine 90mg/m²

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-08-01
• Completion: 2018-12-01
• First posted: 2012-03-23
• Last updated: 2019-01-24

Locations

1 site across 1 country: Belgium