Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma
Related Experiment Video
Updated: Jan 29, 2026
Tumor Treating Field Therapy in Combination with Bevacizumab for the Treatment of Recurrent Glioblastoma
Published on: October 27, 2014
Antonio Silvani1, Irene De Simone2, Vittorio Fregoni3
1Fondazione Istituto Neurologico Carlo Besta, IRCCS, Milan, Italy.
Background And Purpose:
Glioblastoma (GBM) is the most aggressive and frequent subtype of all malignant gliomas. At the time of recurrence, therapeutic options are lacking. Ortataxel, a second-generation taxane was reported to be effective in pre-clinical and phase I clinical studies. The aim of this study was to evaluate a potential therapeutic activity of ortataxel in patients with GBM recurring after surgery and first line treatment.
Methods:
In this phase II study, according to a two stage design, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were considered 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 activity of ortataxel in terms of progression free survival (PFS) at 6 months after the enrollment. PFS, overall survival at 9 months after the enrollment, objective response rate, compliance and safety were evaluated as secondary endpoints.
Results:
Between Nov 26, 2013 and Dec 12, 2015, 40 patients were recruited across six centres. The number of patients alive and free from progression at 6 months after the enrollment, observed in the first stage was four (11.4%), out of 35 patients included in the analysis, below the minimum number of events (7 out of 33) required to continue the study with the second stage The most important toxicities were neutropenia and hepatotoxicity that occurred in 13.2% of patients and leukopenia that occurred in 15.8% of patients.
Conclusion:
Overall ortataxel treatment fail to demonstrate a significant activity in recurrent GBM patients. However in a limited number of patients the drug produced a benefit that lasted for a long time.
Trial Registration:
This study is registered with ClinicalTrials.gov, number NCT01989884.
Insights
Ortataxel did not show significant activity in recurrent glioblastoma (GBM) patients. While some patients experienced prolonged benefits, the overall progression-free survival at six months was low.
Area of Science:
- Neuro-oncology
- Clinical Pharmacology
Background:
- Glioblastoma (GBM) is an aggressive brain cancer with limited treatment options upon recurrence.
- Second-generation taxanes, like ortataxel, have shown promise in preclinical and early clinical studies.
Purpose of the Study:
- To evaluate the therapeutic activity of ortataxel in patients with recurrent GBM.
- To assess progression-free survival (PFS) at 6 months as the primary endpoint.
Main Methods:
- A Phase II, two-stage study enrolled adult patients with recurrent GBM after standard treatment.
- Patients received ortataxel (75 mg/m² IV every 3 weeks) until disease progression.
- Secondary endpoints included overall survival, response rate, compliance, and safety.
Main Results:
- Four out of 35 evaluable patients (11.4%) were progression-free at 6 months, falling below the threshold to proceed to the second stage.
- The study recruited 40 patients between November 2013 and December 2015.
- Key toxicities included neutropenia (13.2%) and leukopenia (15.8%).
Conclusions:
- Ortataxel failed to demonstrate significant efficacy in recurrent GBM patients.
- A subset of patients experienced durable clinical benefit from the treatment.
- Further investigation may be warranted for specific patient populations.
More Related Videos
14:45Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
Published on: September 16, 2012
03:07Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
Related Concept Videos
01:28Inductance: Single-Phase And Three-Phase Line
Single-Phase Two-Wire Line:
A single-phase line consists of two solid cylindrical conductors, denoted as x and y. Each conductor carries phasor currents ix and iy, respectively. Given that the sum of these currents is...
01:25Capacitance: Single-Phase And Three-Phase Line
Single-Phase Lines
Consider a single-phase, two-wire transmission line with equal phase spacing energized by a voltage source. One conductor carries a uniform positive charge, while the other carries an equal negative charge. The capacitance C of the line can be derived from the voltage V between the conductors. For a one-meter section of the line, the capacitance is given...
01:17Power Distribution in Three-phase and Single Phase Circuits
Single-Phase Power Distribution:
Single-phase circuits are typical in household settings;...
01:31Muscles that Move the Arm
The pectoralis major has two origins. Its clavicular head originates on the medial half of the clavicle. In contrast, the sternocostal head originates on the costal cartilages of ribs 1-6, the sternum, and the aponeurosis of the external oblique of the...
01:11Clinical Trials: Overview
01:12Trial and Error and Algorithm