CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Selumetinib +1 moredrug
Likely dose
Selumetinib 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00559949
NCT00559949Phase 2Completed
CompareCT.gov

Phase 2 Study of Selumetinib Hydrogen Sulfate in Iodine-131 Refractory Papillary Thyroid Carcinoma and Papillary Thyroid Carcinoma With Follicular Elements

National Cancer Institute (NCI)·interventional·Posted Nov 19, 2007·Updated Jan 30, 2017

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis and Selumetinib for Recurrent Thyroid Gland Carcinoma and 4 related conditions. Completed, enrolled 39 participants across 6 sites in 2 countries.

Detailed Summary

This phase II trial is studying how well selumetinib works in treating patients with papillary thyroid cancer that did not respond to radioactive iodine. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Thyroid Gland Carcinoma, Stage I Thyroid Gland Papillary Carcinoma, Stage II Thyroid Gland Papillary Carcinoma, Stage III Thyroid Gland Papillary Carcinoma, Stage IV Thyroid Gland Papillary Carcinoma
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 19, 2007
Enrollment StartDec 1, 2007
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 18.6 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Selumetinibdrug

Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary.