Clinical trial · Interventional
Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)
Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma
NCT00948389CI-TRIAL-00007916terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inability to meet protocol objectives
Summary
Brief summary (as posted)
To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Dasatinib
- interventionNames
- Drug: Dasatinib
- type
- ACTIVE_COMPARATOR
- label
- Lomustine
- interventionNames
- Drug: Lomustine
Primary outcomes (5)
- measure
- Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
- timeFrame
- Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).
- description
- SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongation. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related(Tx-R)=certainly, probably, possibly related and unknown relationship to study drug. AE grades(Gr) 1=Mild; 2=Moderate; 3=Severe; 4=Life-threatening.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.