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An Efficacy Study Of Ortataxel In Recurrent Glioblastoma

Study Purpose

Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01989884
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Mario Negri Institute for Pharmacological Research
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Antonio Silvani, MD
Principal Investigator Affiliation Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Study Website: View Trial Website
Additional Details

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).

Arms & Interventions

Arms

Experimental: Ortataxel

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

Interventions

Drug: - Ortataxel

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ospedale di Lecco, Lecco, Italy

Status

Address

Ospedale di Lecco

Lecco, ,

A.O. OSpedale Niguarda Ca' Granda, Milano, Italy

Status

Address

A.O. OSpedale Niguarda Ca' Granda

Milano, ,

Milano, Italy

Status

Address

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, ,

Carlo Besta Neurological Foundation, Milan, Italy

Status

Address

Carlo Besta Neurological Foundation

Milan, , 20133

Fondazione "Salvatore Maugeri", Pavia, Italy

Status

Address

Fondazione "Salvatore Maugeri"

Pavia, ,

IRCCS Fondazione "Casimiro Mondino", Pavia, Italy

Status

Address

IRCCS Fondazione "Casimiro Mondino"

Pavia, ,

Istituti Fisioterapici Ospitalieri, Rome, Italy

Status

Address

Istituti Fisioterapici Ospitalieri

Rome, ,

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