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NCT00428597 · ClinicalTrials.gov registry record · Phase 3
A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 171
- Enrollment target
NCT00428597 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 171 participants.
The verdict
NCT00428597, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 171 participants
- Enrollment target
Study Summary
This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug. The study was designed to detect a 50% improvement in median PFS\[Progression Free Survival\] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred. Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC \[Data Monitoring Committee\]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.
Interventions
- DRUG Placebo
- DRUG sunitinib malate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00428597
The ClinicalTrials.gov registry entry for NCT00428597 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 171 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00428597 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00428597 about?
NCT00428597 is a clinical study titled "A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors". This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patie...
What is the current status of trial NCT00428597?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 171 participants. The study started on 2007-06. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00428597?
The interventions under investigation include: Placebo (DRUG), sunitinib malate (DRUG).
Who is sponsoring clinical trial NCT00428597?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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