CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Gefitinibdrug
Likely dose
Gefitinib orally once dailyAI-extracted
Key inclusion· 5
  • ✓Histologically or cytologically confirmed thyroid cancer, metastatic or locally advanced, not amenable or refractory to local therapy and/or radioactive iodine
  • ✓Thyroid cancer unresponsive or refractory to radioactive iodine (medullary and anaplastic considered unresponsive by histology; well-differentiated considered refractory if no uptake on scan or tumor growth despite treatment)
  • ✓Measurable disease
  • ✓Age at least 18 years
Key exclusion· 12
  • ✕Concurrent chemotherapy, systemic anticancer treatment, or radiation therapy
  • ✕Treatment with investigational drug within 30 days before Day 1
  • ✕Pregnant or nursing
  • ✕Absolute neutrophil count <1.5 × 10^9/L, platelet count <75 × 10^9/L, bilirubin >1.5× normal, ALT or AST >3× normal

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

Search/NCT00095836
NCT00095836Phase 2Completed
CompareCT.gov

A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer

Massachusetts General Hospital·interventional·Posted Nov 9, 2004·Updated May 31, 2017

In Brief

A Phase 2 clinical trial evaluating Gefitinib for Head and Neck Cancer. Completed, enrolled 27 participants across 2 sites.

Detailed Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic thyroid cancer that did not respond to iodine therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Dana-Farber Cancer Institute, Brigham and Women's Hospital, AstraZeneca

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2004
Enrollment StartMar 1, 2003
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 21.6 years ago

Interventions

Gefitinibdrug

Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.