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An Efficacy Study Of Ortataxel In Recurrent Glioblastoma (Ortataxel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01989884
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989884


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

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT01989884    
Other Study ID Numbers: IRFMN-GBM-6272
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: November 2014
Additional relevant MeSH terms:
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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