Clinical trial · Interventional
Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)
A Phase I/II, Two-arm, Multicenter, Dose Escalation Study of Oral AEE788 Administered on a Continuous Once Daily Dosing Schedule in Adult Patients With Recurrent or Relapsing Glioblastoma Multiforme
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.
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 Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AEE788 | Drug | Multikinase Inhibitor AEE788 | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AEE788 + non EIACD
- interventionNames
- Drug: AEE788
- type
- EXPERIMENTAL
- label
- AEE788 + EIACD
- interventionNames
- Drug: AEE788
Primary outcomes (2)
- measure
- Maximum tolerated dose
- timeFrame
- 2 years
- measure
- Dose limiting toxicity
- timeFrame
- 2 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed GBM in first or second recurrence or relapse * Adequate hematologic, hepatic and renal function * Age ≥ 18 years * Karnofsky performance status score ≥ 70% * Life expectancy ≥ 12 weeks Exclusion Criteria: * Peripheral neuropathy \> grade 1 * Diarrhea \> grade 1 * Gastrointestinal dysfunction * Compromised cardiac function * Concurrent severe and/or uncontrolled medical conditions
References
Publications (0)
Data not yet available