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Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)

Study Purpose

To determine whether dasatinib plus lomustine are effective for treatment of 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:

  • - Patients with histological or cytological proven glioblastoma multiforme.
  • - Recurrent or progressive disease documented by magnetic resonance imaging (MRI) - World Health Organization (WHO) Performance status 0 - 2.
  • - Patient may have been operated for recurrence.
  • - For non operated patients, recurrent disease must be at least one bidimensionally measurable target lesion with one diameter of at least 2cm.
  • - Patients must be on a stable or decreasing dose of corticosteroids for at least 1 week prior to baseline MRI.

Exclusion Criteria:

  • - Patients with histological or cytological proven glioblastoma multiforme.
  • - Completion of radiotherapy to the brain less than 3 months prior to registration/randomization.
  • - Prior treatment with high dose radiotherapy, stereotactic radiosurgery or internal radiation therapy.
- Previous or current malignancy at other sites within prior 3 years

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.

 NCT00948389
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.

 Bristol-Myers Squibb
Principal Investigator

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

 Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

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

 Industry, Other
Overall Status Terminated
Countries France, Italy, Netherlands, Switzerland
Conditions

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

 Glioblastoma
Study Website: View Trial Website
Arms & Interventions

Arms

Active Comparator: Dasatinib

Active Comparator: Lomustine

Interventions

Drug: - Dasatinib

Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity

Drug: - Lomustine

Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity

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

Local Institution, Paris Cedex, France

Status

Address

Local Institution

Paris Cedex, , 75013

Local Institution, Bologna, Italy

Status

Address

Local Institution

Bologna, , 40139

Local Institution, Nijmegen, Netherlands

Status

Address

Local Institution

Nijmegen, , 6525 GA

Local Institution, Rotterdam, Netherlands

Status

Address

Local Institution

Rotterdam, , 3075 EA

Local Institution, Lausanne, Switzerland

Status

Address

Local Institution

Lausanne, , 1011

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