An Efficacy Study Of Ortataxel In Recurrent Glioblastoma (Ortataxel)
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ClinicalTrials.gov Identifier: NCT01989884 |
Recruitment Status :
Completed
First Posted : November 21, 2013
Last Update Posted : October 23, 2019
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Condition or disease | Intervention/treatment | Phase |
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Glioblastoma | Drug: Ortataxel | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Ortataxel
75 on day 1 every 21 days mg/m2 milligram(s)/square meter (intravenous use)
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Drug: Ortataxel
75 mg/m2, IV (in the vein) every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: IDN5109 |
- 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
- 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
- Overall survival-9 [ Time Frame: 9 months after randomization ]defined as the percentage of patients who are alive at 9 months after the randomization.
- 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
- 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).
- treatment compliance [ Time Frame: 9 months after randomization ]-Dose-intensity, -percentage of patients with dose and/or time modifications, - Percentage of premature withdrawals

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
- Surgery must have confirmed the recurrence.
- 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.
- 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

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
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 |
Principal Investigator: | Antonio Silvani, MD | Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano |
Study Data/Documents: Clinical Study Report

Publications of Results:
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 |
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 |