A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors
Public ClinicalTrials.gov record NCT00428597. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00428597
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 171 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2007
- Primary completion
- Mar 31, 2009
- Completion
- Mar 31, 2009
- Last update posted
- Oct 10, 2010
2007 – 2009
United States locations
- U.S. sites
- 14
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pfizer Investigational Site | Aurora | Colorado | 80045 | — |
| Pfizer Investigational Site | Iowa City | Iowa | 52242 | — |
| Pfizer Investigational Site | Worcester | Massachusetts | 01605 | — |
| Pfizer Investigational Site | Worcester | Massachusetts | 01655 | — |
| Pfizer Investigational Site | City of Saint Peters | Missouri | 63376 | — |
| Pfizer Investigational Site | Creve Coeur | Missouri | 63141 | — |
| Pfizer Investigational Site | St Louis | Missouri | 63110-1094 | — |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | — |
| Pfizer Investigational Site | Austin | Texas | 78705 | — |
| Pfizer Investigational Site | Austin | Texas | 78745 | — |
| Pfizer Investigational Site | Austin | Texas | 78758 | — |
| Pfizer Investigational Site | Austin | Texas | 78759 | — |
| Pfizer Investigational Site | Georgetown | Texas | 78626 | — |
| Pfizer Investigational Site | Norfolk | Virginia | 23510 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00428597, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 10, 2010 · Synced Sep 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00428597 live on ClinicalTrials.gov.