NCT01989884

An Efficacy Study Of Ortataxel In Recurrent Glioblastoma

Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma

Detailed description

In this phase II study, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were eligible. Patients included were treated with ortataxel 75 mg/m² i.v. every 3 weeks until disease progression. The primary objective of the study was to evaluate the efficacy of ortataxel in terms of progression free survival at six months after the enrolment (PFS-6).

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Ortataxel	75 mg/m2, IV (in the vein) every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2013-11-21
• Last updated: 2019-10-23

Locations

7 sites across 1 country: Italy