drugset / Trial / NCT01208051

Cediranib Maleate With or Without Lenalidomide for the Treatment of Thyroid Cancer

NCT01208051 ↗

Phase 1/2 Completed 127 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This partially randomized phase I/II trial studies the side effects and best dose of cediranib maleate when given together with or without lenalidomide and to see how well they work in treating patients with thyroid cancer. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of thyroid cancer by blocking blood flow to the tumor. It is not yet known whether cediranib maleate is more effective when given together with lenalidomide in treating thyroid cancer.

Timeline

Start
2010-09-09
Primary completion
2020-02-01
Completion
2020-02-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Phase II Arm A (Cediranib Maleate) vs Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015); p = 0.26; Log Rank; note: p-value is stratified by randomization factors. NCT01208051 ↗

registry analysis (superiority test); Phase II Arm A (Cediranib Maleate) vs Phase II Arm B (Cediranib Maleate Plus Lenalidomide); p = 0.36; Log Rank NCT01208051 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cediranib Small molecule 30 mg Oral
Subject Lenalidomide Other / unclassified 15 mg Oral