CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
everolimus +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically confirmed NSCLC: Stage IIIB (unresectable with malignant pleural/pericardial effusion), Stage IV, or recurrent disease
  • ✓Measurable or evaluable indicator lesions
  • ✓Progressive disease after ≥1 prior chemotherapy regimen containing cisplatin or carboplatin AND docetaxel
  • ✓Age ≥18 years
Key exclusion· 7
  • ✕Uncontrolled brain or leptomeningeal metastases or those requiring concurrent glucocorticoids for control
  • ✕Prior EGFR TKI therapy (gefitinib, erlotinib, or other EGFR TKI)
  • ✕Congestive heart failure, NYHA class III-IV heart disease, or unstable angina
  • ✕Severe infection, severe malnutrition, or other serious medical illness

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

Search/NCT00096486
NCT00096486Phase 2Completed
CompareCT.gov

A Phase I/II Trial of Fixed Doses of Daily Gefitinib With Escalating Doses of Daily RAD001 in Advanced Non-Small Cell Lung Cancer

Memorial Sloan Kettering Cancer Center·interventional·Posted Nov 10, 2004·Updated Jan 21, 2016

In Brief

A Phase 2 clinical trial evaluating everolimus and gefitinib for Lung Cancer. Completed, enrolled 74 participants across 1 site.

Detailed Summary

RATIONALE: Gefitinib and everolimus may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving gefitinib together with everolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects, best way to give, and best dose of giving gefitinib with everolimus and to see how well it works in treating patients with stage IIIB or stage IV or recurrent non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 10, 2004
Enrollment StartMay 1, 2004
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 21.6 years ago

Interventions

everolimusdrug

gefitinibdrug