NCT01989884

Brief Summary

Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2013

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 23, 2019

Status Verified

November 1, 2014

Enrollment Period

2.1 years

First QC Date

October 23, 2013

Last Update Submit

October 21, 2019

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

  • progression free survival-6

    defined as the percentage of patients who are alive and progression free at 6 months after the randomization

    after 6 months after randomization

Secondary Outcomes (5)

  • progression free survival

    after 9 months of follow-up for each patient

  • Overall survival-9

    9 months after randomization

  • Objective response rate

    after 9 months of follow-up for each patient

  • Number of patients with AEs, SAEs, SADRs, SUSARs

    after 9 months of follow-up for each patient

  • treatment compliance

    9 months after randomization

Study Arms (1)

Ortataxel

EXPERIMENTAL

75 on day 1 every 21 days mg/m2 milligram(s)/square meter (intravenous use)

Drug: Ortataxel

Interventions

OrtataxelDRUG

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

Also known as: IDN5109
Ortataxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ospedale di Lecco

Lecco, Italy

Location

Carlo Besta Neurological Foundation

Milan, 20133, Italy

Location

A.O. OSpedale Niguarda Ca' Granda

Milan, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Fondazione "Salvatore Maugeri"

Pavia, Italy

Location

IRCCS Fondazione "Casimiro Mondino"

Pavia, Italy

Location

Istituti Fisioterapici Ospitalieri

Rome, Italy

Location

Related Publications (1)

  • 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.

    PMID: 30726533RESULT

Related Links

MeSH Terms

Conditions

Glioblastoma

Interventions

IDN 5109

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Antonio Silvani, MD

    Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 21, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

October 23, 2019

Record last verified: 2014-11

Locations

IT(7)