Italian study on the efficacy of Ortataxel in recurrent Glioblastoma
- Conditions
- Glioblastoma in recurrence/progression after surgery (or biopsy), radiotherapy and chemotherapy with temozolomideTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003618-15-IT
- Lead Sponsor
- IRCCS - Istituto di Ricerche Farmacologiche Mario Negri
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Histologically confirmed GBM.
- GBM in recurrence/progression after surgery, standard radiotherapy and chemotherapy with Temozolomide.
- Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria.
- No more than one prior line of chemotherapy (Temozolomide).
- Recovery from the toxic effects of prior therapy.
- Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
a)Surgery must have confirmed the recurrence.
b)A minimum of 14 days must have elapsed from the day of surgery to randomization. For core or needle biopsy, a minimum of 7 days must have elapsed prior to randomization.
c)Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomization.
- Age = 18 years.
- Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
- Karnofsky-PS = 60%.
- Stable or decreasing dose of corticosteroids within 5 days prior to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- Patients unable to undergo brain MRI scans with gadolinium (iv).
- Pre-existing peripheral neuropathy, grade = 2.
- History of intracranial abscess within 6 months prior to randomization.
- Anticipation of need for major surgical procedure during the course of the trial.
- Treatment with enzyme inducing antiepileptic agents was not allowed. However, patients whose anticonvulsant was changed to a non-enzymeinducing antiepileptic drug were eligible for entry after a 1-week ‘‘washout’’ period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Ortataxel in terms of PFS-6, defined as the percentage of patients who are alive and progression free at 6 months after the randomization. Fotemustine will act as a calibration arm;Secondary Objective: To evaluate:<br>- percentage of survival patients after 9 months from the randomization.<br>- percentage of patients who are judged by the Investigators to have an objective response as determined by the RANO criteria.<br>- the treatment compliance. <br>- the safety profile.;Primary end point(s): 6-months progression-free survival (PFS-6), defined as the percentage of patients who are alive and progression free at 6 months after the randomization<br>;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): PFS<br>OS-9<br>ORR<br>Dose-intensity<br>Percentage of patients with dose and/or time modifications<br>Percentage of premature withdrawals<br>Incidence, nature, severity and seriousness of AEs<br>Maximum toxicity grade experienced by each patient for each specific toxicity <br>Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity<br>Patients with at least a SAE<br>Patients with at least a serious adverse drug reaction (SADR)<br>Patients with at least a suspect unexpected serious adverse reaction (SUSAR).<br>;Timepoint(s) of evaluation of this end point: 9 months