Clinical trial · Interventional
Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme
Phase I Study of Erlotinib Administered Every 72 Hours in Patients With Glioblastoma Multiforme With Pharmacokinetic/Pharmacodynamic Correlates
NCT00227032CI-TRIAL-00006383terminatedPhase 1ClinicalTrials.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): Loss of funding
Summary
Brief summary (as posted)
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib in treating patients with progressive glioblastoma multiforme.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Subjects receiving EIAEDs
- description
- Patients will be stratified according to concurrent use of enzyme inducing anti-epileptic drugs (EIAED)
- interventionNames
- Drug: erlotinib hydrochloride
- type
- EXPERIMENTAL
- label
- Subjects NOT taking EIAEDs
- description
- Patients will be stratified according to concurrent use of enzyme inducing anti-epileptic drugs (EIAED)
- interventionNames
- Drug: erlotinib hydrochloride
Primary outcomes (2)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme (or high-grade glioma that is behaving clinically and/or radiographically like glioblastoma multiforme) * Progressed after first-line therapy (e.g., surgery, chemotherapy, or radiotherapy) PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * ANC \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Hemoglobin \> 8.5 g/dL * ALT and AST \< 2 times upper limit of normal (ULN) * Alkaline phosphatase \< 2 times ULN * Bilirubin \< 1.5 mg/dL * Creatinine \< 1.5 mg/dL OR creatinine clearance \> 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No diagnosis or history of significant renal or hepatic disease * No contraindication (e.g., mass effect, brain shift) to lumbar puncture procedure * No active infection * No diagnosis or history of corneal abnormalities * No diagnosis or history of malabsorptive syndrome or other disorder affecting gastrointestinal absorption * No history of hypersensitivity reactions to midazolam hydrochloride (CYP3A4 biomarker) PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.