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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: Clinical Trial Phase 2 study, sponsored by Weill Medical College of Cornell University.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluation of Target lesions: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum onstudy (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must al
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 |
Why NCT03930771 stopped before completion
NCT03930771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT03930771 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03930771's enrollment target sits among peer trials
1 2001st 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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