An Efficacy Study Of Ortataxel In Recurrent Glioblastoma

Glioblastoma Clinical Trial

— Ortataxel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989884
• Other study ID #: IRFMN-GBM-6272
• Status: Completed
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: November 2014
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed GBM.

• GBM in recurrence/progression after surgery (or biopsy), 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:

1. Surgery must have confirmed the recurrence.

2. A minimum of 14 days must have elapsed from the day of surgery to registration. For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration.

3. 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 registration.

• 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 registration.

Exclusion Criteria:

• 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 registration.

• 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 nonenzymeinducing antiepileptic drug were eligible for entry after a 1-week ''washout'' period

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale di Lecco	Lecco
Italy	Carlo Besta Neurological Foundation	Milan
Italy	A.O. OSpedale Niguarda Ca' Granda	Milano
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	Fondazione "Salvatore Maugeri"	Pavia
Italy	IRCCS Fondazione "Casimiro Mondino"	Pavia
Italy	Istituti Fisioterapici Ospitalieri	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Silvani A, De Simone I, Fregoni V, Biagioli E, Marchioni E, Caroli M, Salmaggi A, Pace A, Torri V, Gaviani P, Quaquarini E, Simonetti G, Rulli E, D'Incalci M; Italian Association of Neuro-Oncology. Multicenter, single arm, phase II trial on the efficacy o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival-6	defined as the percentage of patients who are alive and progression free at 6 months after the randomization	after 6 months after randomization
Secondary	progression free survival	defined for each patient as the time from the date of randomization to the date of first progression, second primary malignancy or death from any cause, whichever comes first. Subjects not progressed or died at the time of the analysis will be censored at the last disease assessment date	after 9 months of follow-up for each patient
Secondary	Overall survival-9	defined as the percentage of patients who are alive at 9 months after the randomization.	9 months after randomization
Secondary	Objective response rate	defined as the percentage of patients who are judged by the Investigators to have an objective response as determined by the RANO criteria	after 9 months of follow-up for each patient
Secondary	Number of patients with AEs, SAEs, SADRs, SUSARs	Incidence, nature, severity and seriousness of AEs, according of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0; Maximum toxicity grade experienced by each patient for each specific toxicity; Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity; Patients with at least a SAE; Patients with at least a serious adverse drug reaction (SADR); Patients with at least a suspect unexpected serious adverse reaction (SUSAR).	after 9 months of follow-up for each patient
Secondary	treatment compliance	-Dose-intensity, -percentage of patients with dose and/or time modifications, - Percentage of premature withdrawals	9 months after randomization

External Links

•   journal article