CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Sunitinib +1 moredrug
Likely dose
Sunitinib 50mgfrom 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/NCT01621568
NCT01621568Phase 2Completed

A Phase II Study of Sunitinib in Patients With Advanced Relapsed or Refractory Thymoma or Thymic Carcinoma With at Least One Prior Line of Platinum-Based Systemic Chemotherapy

National Cancer Institute (NCI)·interventional·Posted Jun 18, 2012·Updated Sep 24, 2024

In Brief

A Phase 2 clinical trial evaluating Sunitinib for Thymoma and Thymus Neoplasms. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Background: \- Sunitinib is drug that is approved for treating various types of cancers, including kidney cancers. However, it has not been approved to treat cancers of the thymus. Sunitinib works by blocking proteins that are responsible for cell division and growth. Some of these proteins can be found on thymus cancer cells. Researchers want to see if sunitinib can be used to treat advanced thymus cancer. It will be given to people who have had at least one earlier chemotherapy treatment containing platinum. Objectives: \- To see if sunitinib is a safe and effective treatment for advanced thymus cancer that has not responded to earlier treatments. Eligibility: * Individuals at least 18 years of age who have advanced thymus cancer that has not responded to earlier treatments. * At least one previous cancer treatment must have been chemotherapy treatment containing platinum. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and tumor biopsies will be used to check the severity of the cancer. * Participants will take sunitinib tablets once a day, in the morning. They will take the tablets daily for 4 weeks, followed by 2 weeks of rest with no sunitinib. This 6-week period is called a cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Treatment cycles may be repeated as long as the tumor does not continue to grow and there are no severe side effects....

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsIndiana University

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 18, 2012
Enrollment StartMay 15, 2012
Primary CompletionApr 30, 2021
Study CompletionJul 31, 2024
TodayJul 2, 2026
Enrollment to primary: 9.0 yearsPosted 14.0 years ago

Interventions

Sunitinibdrug

50mg/day for 4 weeks daily, by mouth with 2 weeks off (6 week cycle)

Sunitinibdrug

50mg/day for 2 weeks daily, by mouth with 1 week off (3 week cycle)