NCT00116376CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 64
- Locations
- 4
- Primary Endpoint
- Maximum tolerated dose
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AEE788 + non EIACD
Experimental
Intervention: AEE788 (Drug)
AEE788 + EIACD
Experimental
Intervention: AEE788 (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose
Time Frame: 2 years
Dose limiting toxicity
Time Frame: 2 years
Secondary Outcomes
- Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels(2 years)
Investigators
Study Sites (4)
Loading locations...
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