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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: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT00428597 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 171 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time from randomization to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS was calculated as (first event date minus first randomization date +1) divided by 30.4.
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 |
Why NCT00428597 stopped before completion
NCT00428597 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00428597 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00428597's enrollment target sits among peer trials
171 1451st of 2000 higher than 548 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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