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Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma

Study Purpose

Patupilone trial for patients with recurrent glioblastoma, which are planned for re-operation. Objectives: prolongation of PFS compared to patients with re-operation only, Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre

  • - and post Patupilone.
Translational research of tumor tissue exposed to patupilone. - Trial with medicinal product

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 - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria:

  • - Recurrent glioblastoma at least 2 cm in diameter after standard treatment (Surgery, Radiotherapy and Chemotherapy), which has to be completed at least three weeks earlier.
  • - > 18 years of age, KPS 70-100% - No liver disease, no malignancies (except curative treated skin tumors, DCIS of the breast and curative treated cervix carcinoma) - Lc > 3000 und Tc > 100 000, Hb> 9, Bilirubin
  • - No pregnancy or breast feeding.
  • - Written Informed Consent prior to study entry.
  • - No reasons for incompliance.
  • - Reoperation planned.

Exclusion criteria:

  • - KPS < 70% - Radiotherapy- or Chemotherapy within 6 weeks.
  • - Enzyme inducing medication or St John's wort.
  • - Other study medication within 28 days.
  • - Other malignancies.
  • - Intolerance of Patupilone.
  • - Prior Patupilone.
  • - Neuropathy > Grad 1.
  • - Other life threatening illnesses.
  • - Acute or chronic liver diseases.
  • - HIV Infection.
  • - Known non-compliance in medication intake,inability to give informed consent.
  • - Cardiac problems (NYHA III oder IV) with uncontrolled insufficiency or angina pectoris.
  • - Active or uncontrolled infection.
  • - Pregnancy or breast feeding.
  • - Hematologic Growth Factors (without Erythropoetin) colostomy.
  • - Patients with uncontrolled diarrhea in the last 7 days prior to study entry.

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.

 NCT00715013
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 1/Phase 2
Lead Sponsor

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

 University of Zurich
Principal Investigator

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

 Silvia Hofer, MD
Principal Investigator Affiliation UniversitaetsSpital Zuerich
Agency Class

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

 Other
Overall Status Completed
Countries
Conditions

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

 Recurrent Glioblastoma Planned for Reoperation
Additional Details

Prior to and after re-operation patients with recurrent glioblastoma receive the investigational drug Patupilone, a tubulin-inhibitor. The purpose of the trial is to prolong PFS in this patient population. Patupilone is already used in clinical trials of other tumor entities such as ovarian cancer, breast and lung cancer. Side effects are expected to be manageable.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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