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NCT03641326 · ClinicalTrials.gov registry record · Phase 2
Sunitinib in Sarcomas of the Central Nervous System
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT03641326: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03641326 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03641326, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: A sarcoma is a rare cancer. It grows in the body's connective tissue. Sarcomas in the brain and central nervous system are especially rare. The drug Sunitinib has been approved in many countries for treating other types of rare or advanced cancers. These include kidney, pancreas, and bowel cancer. Researchers want to see if it can help people with sarcomas of the central nervous system. Objective: To study the effects of Sunitinib on gliosarcomas or sarcomas of the central nervous system. Eligibility: Adults ages 18 and older with a gliosarcoma or sarcoma of the central nervous system Design: Participants will be screened with the following tests. Some may be done as part of their regular cancer care: Medical history Medication review Physical exam Blood, heart, and pregnancy tests Cranial scans to locate and measure their tumor Participants will take Sunitinib by mouth every day for 2 weeks and then take none of the drug for 1 week. These 3 weeks equal 1 cycle. Participants will have 2 study visits in cycle 1. They will have 1 visit in all other cycles. They will answer questions about quality of life and repeat some screening tests. Participants will take their blood pressure at home weekly. They keep a diary of each dose of Sunitinib and blood pressure reading. Participants can choose to share data about their physical activity levels and quality of sleep. These participants will wear a small, portable watch-sized accelerometer device on the wrist for 6 cycles. About 1 month after their last study drug dose, participants will have a final study visit. They will have a physical exam, blood tests, and scans.
Primary Outcome
Objective Response is defined as all participants who had greater than 50% reduction in Complete Response and Partial Response assessed by the Assessment in Neuro-oncology Criteria (RANO criteria). Complete Response is no T1 gadolinium enhancing disease, no new lesions, or corticosteroids, and stable or decreasing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) or clinical status. Partial Response is ≥50% decrease in T1 gadolinium enhancing disease, no new lesions, stable or decreasin
Interventions
- DRUG Sunitinib
- DEVICE wGT3x-BT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-02-21 |
| Est. Completion | 2021-04-02 |
| Phase | Phase 2 |
Why NCT03641326 stopped before completion
NCT03641326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Sunitinib is the first listed.
NCT03641326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03641326 about?
NCT03641326 is a clinical study titled "Sunitinib in Sarcomas of the Central Nervous System". Background: A sarcoma is a rare cancer. It grows in the body's connective tissue. Sarcomas in the brain and central nervous system are especially rare. The drug Sunitinib has been approved in many countries for treating other types of rare or advanced cancers. These include kidney, pancreas, and bo...
What is the current status of trial NCT03641326?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2019-02-21. Estimated completion is 2021-04-02.
What interventions are being tested in trial NCT03641326?
The interventions under investigation include: Sunitinib (DRUG), wGT3x-BT (DEVICE).
Who is sponsoring clinical trial NCT03641326?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03641326's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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