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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

Tracking Information
First Submitted Date  ICMJE October 23, 2013
First Posted Date  ICMJE November 21, 2013
Last Update Posted Date October 23, 2019
Study Start Date  ICMJE November 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2013)
  • 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
  • safety profile [ Time Frame: after 9 months of follow-up for each patient ]
  • treatment compliance [ Time Frame: 9 months after randomization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy Study Of Ortataxel In Recurrent Glioblastoma
Official Title  ICMJE Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma
Brief Summary Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE Drug: Ortataxel
75 mg/m2, IV (in the vein) every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: IDN5109
Study Arms  ICMJE Experimental: Ortataxel
75 on day 1 every 21 days mg/m2 milligram(s)/square meter (intravenous use)
Intervention: Drug: Ortataxel
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2019)
45
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2013)
100
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01989884
Other Study ID Numbers  ICMJE IRFMN-GBM-6272
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mario Negri Institute for Pharmacological Research
Study Sponsor  ICMJE Mario Negri Institute for Pharmacological Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Silvani, MD Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano
PRS Account Mario Negri Institute for Pharmacological Research
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP