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NCT01621568 · ClinicalTrials.gov registry record · Phase 2
Sunitinib for Advanced Thymus Cancer Following Earlier Treatment
A Phase 2 study of Thymoma and Thymus Neoplasms, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT01621568: Completed Phase 2 study of Thymoma and Thymus Neoplasms, sponsored by National Cancer Institute (NCI).
NCT01621568 is a Phase 2 study of Thymoma and Thymus Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 56 participants, below the 138-participant average among 9 other Thymoma trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01621568, a Phase 2 study of Thymoma and Thymus Neoplasms, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study 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....
Primary Outcome
Objective response rate (CR + PR) will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for sunitinib monotherapy in participants with advanced thymic malignancies. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Conditions Studied
Interventions
- DRUG Sunitinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-05-15 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 2 |
What the finished NCT01621568 record still lists
NCT01621568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 138-participant average among 9 other Thymoma trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Thymoma appearing as the primary indexed condition, and to 1 intervention - of which Sunitinib is the first listed.
NCT01621568 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01621568 about?
NCT01621568 is a clinical study titled "Sunitinib for Advanced Thymus Cancer Following Earlier Treatment". 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 ...
What is the current status of trial NCT01621568?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2012-05-15. Estimated completion is 2024-07-31.
What conditions does trial NCT01621568 study?
This clinical trial studies the following conditions: Thymoma, Thymus Neoplasms.
What interventions are being tested in trial NCT01621568?
The interventions under investigation include: Sunitinib (DRUG).
Who is sponsoring clinical trial NCT01621568?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01621568 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01621568's enrollment target sits among peer trials
56 2nd of 9 higher than 7 of 9 other Thymoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thymoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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