An Efficacy Study Of Ortataxel In Recurrent Glioblastoma (Ortataxel)

• ClinicalTrials.gov Identifier: NCT01989884
• Recruitment Status: Completed
• First Posted: November 21, 2013
• Last Update Posted: October 23, 2019
• Sponsor: Mario Negri Institute for Pharmacological Research
• Information provided by (Responsible Party): Mario Negri Institute for Pharmacological Research

Study Description

Brief Summary:

Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma

Condition or disease	Intervention/treatment	Phase
Glioblastoma	Drug: Ortataxel	Phase 2

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma
• Study Start Date: November 2013
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ortataxel; 75 on day 1 every 21 days mg/m2 milligram(s)/square meter (intravenous use)	Drug: Ortataxel; 75 mg/m2, IV (in the vein) every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.; Other Name: IDN5109

Outcome Measures

Primary Outcome Measures :

1. progression free survival-6 [ Time Frame: after 6 months after randomization ]
   defined as the percentage of patients who are alive and progression free at 6 months after the randomization

Secondary Outcome Measures :

1. progression free survival [ Time Frame: after 9 months of follow-up for each patient ]
   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
2. Overall survival-9 [ Time Frame: 9 months after randomization ]
   defined as the percentage of patients who are alive at 9 months after the randomization.
3. Objective response rate [ Time Frame: after 9 months of follow-up for each patient ]
   defined as the percentage of patients who are judged by the Investigators to have an objective response as determined by the RANO criteria
4. Number of patients with AEs, SAEs, SADRs, SUSARs [ Time Frame: after 9 months of follow-up for each patient ]
   • 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).
5. treatment compliance [ Time Frame: 9 months after randomization ]
   -Dose-intensity, -percentage of patients with dose and/or time modifications, - Percentage of premature withdrawals

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Italy

Ospedale di Lecco

Lecco, Italy

A.O. OSpedale Niguarda Ca' Granda

Milano, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy

Carlo Besta Neurological Foundation

Milan, Italy, 20133

Fondazione "Salvatore Maugeri"

Pavia, Italy

IRCCS Fondazione "Casimiro Mondino"

Pavia, Italy

Istituti Fisioterapici Ospitalieri

Rome, Italy

Sponsors and Collaborators

Mario Negri Institute for Pharmacological Research

Investigators

• Principal Investigator: Antonio Silvani, MD; Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano

More Information

Additional Information:

journal article 

Study Data/Documents: Clinical Study Report 

Publications of Results:

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 of ortataxel in recurrent glioblastoma. J Neurooncol. 2019 May;142(3):455-462. doi: 10.1007/s11060-019-03116-z. Epub 2019 Feb 6.

• Responsible Party: Mario Negri Institute for Pharmacological Research
• ClinicalTrials.gov Identifier: NCT01989884
• Other Study ID Numbers: IRFMN-GBM-6272
• First Posted: November 21, 2013
• Last Update Posted: October 23, 2019
• Last Verified: November 2014

Additional relevant MeSH terms:

Glioblastoma; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; IDN 5109; Antineoplastic Agents