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NCT03930771 · ClinicalTrials.gov registry record · Phase 2
Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT03930771 is a Phase 2 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 1 participants.
The verdict
NCT03930771, a Phase 2 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is an open label study to assess the efficacy of capecitabine (CAP) and temozolomide (TMZ) in recurrent pituitary adenomas. There will be a safety run-in of at least three patients to establish any dose limiting toxicities. Enrolled patients will receive treatment in 28-day cycles: capecitabine 1500mg/m2 per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14 and oral temozolomide 150 to 200 mg/m2 on days 10 through 14. This will be followed by 14 days off treatment. MRI imaging will be completed after every two cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Interventions
- DRUG Capecitabine
- DRUG Temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-05-21 |
| Est. Completion | 2021-10-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03930771
The ClinicalTrials.gov registry entry for NCT03930771 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT03930771 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03930771 about?
NCT03930771 is a clinical study titled "Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas". This is an open label study to assess the efficacy of capecitabine (CAP) and temozolomide (TMZ) in recurrent pituitary adenomas. There will be a safety run-in of at least three patients to establish any dose limiting toxicities. Enrolled patients will receive treatment in 28-day cycles: capecitabine...
What is the current status of trial NCT03930771?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-05-21. Estimated completion is 2021-10-01.
What interventions are being tested in trial NCT03930771?
The interventions under investigation include: Capecitabine (DRUG), Temozolomide (DRUG).
Who is sponsoring clinical trial NCT03930771?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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