CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 136 enrolled
Drug / intervention
erlotinib hydrochloride +2 moredrug
Likely dose
Not specified in interventions or armsAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed intracranial malignant glioma (GBM, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, malignant astrocytoma NOS) or histologically/radiographically confirmed recurrent or progressive meningioma
  • ✓Progressive disease or tumor recurrence on imaging
  • ✓Phase I: ≤3 prior relapses and ≤2 prior chemotherapy or biologic therapy regimens; Phase II: ≤2 prior relapses and ≤2 prior chemotherapy or biologic therapy regimens
  • ✓Prior radiotherapy completed ≥4 weeks ago for progressive disease; patients with GBM without progression after external beam radiotherapy are eligible; progression 4–12 weeks post-radiotherapy requires clear MRI evidence
Key exclusion· 7
  • ✕No active infection
  • ✕No other serious concurrent medical illness
  • ✕No other malignancy within past 3 years except nonmelanoma skin cancer or carcinoma in situ of cervix
  • ✕No disease that would obscure toxicity or dangerously alter drug metabolism

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00045110
NCT00045110Phase 2Completed
CompareCT.gov

A Phase I/II Trial of OSI-774 in Patients With Recurrent Malignant Gliomas and Malignant Gliomas Post Radiation Therapy

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated Aug 17, 2017

In Brief

A Phase 2 clinical trial evaluating erlotinib hydrochloride, laboratory biomarker analysis, and 1 other intervention for Adult Anaplastic Astrocytoma and 8 related conditions. Completed, enrolled 136 participants across 7 sites.

Detailed Summary

Phase I/II trial to study the effectiveness of erlotinib in treating patients who have recurrent malignant glioma or recurrent or progressive meningioma. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Grade I Meningioma, Adult Grade II Meningioma, Adult Grade III Meningioma, Recurrent Adult Brain Tumor
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartAug 1, 2002
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 23.4 years ago

Interventions

erlotinib hydrochloridedrug

given orally

laboratory biomarker analysisother

correlative studies

pharmacological studyother

correlative studies