MedDataX Logo

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

NCT ID: NCT00948389

Last Updated: 2012-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dasatinib

Group Type ACTIVE_COMPARATOR

Dasatinib

Intervention Type DRUG

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

Lomustine

Group Type ACTIVE_COMPARATOR

Lomustine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dasatinib

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

Intervention Type DRUG

Lomustine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BMS-354825

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

Paris, , France

Site Status

Local Institution

Bologna, , Italy

Site Status

Local Institution

Nijmegen, , Netherlands

Site Status

Local Institution

Rotterdam, , Netherlands

Site Status

Local Institution

Lausanne, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Germany Israel United Kingdom France Italy Netherlands Switzerland

Related Links

Access external resources that provide additional context or updates about the study.

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Protocol 26083

Identifier Type: OTHER

Identifier Source: secondary_id

2009-010576-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA180-274

Identifier Type: -

Identifier Source: org_study_id