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NCT Number: NCT01989884

An Efficacy Study Of Ortataxel In Recurrent Glioblastoma

Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale di Lecco, Lecco, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

ortataxel

Drug

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

Other names: IDN5109

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Registry information

Official study title

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

Acronym: Ortataxel

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Nov 21, 2013
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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