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A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors

NCT ID: NCT00428597

Last Updated: 2010-10-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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The study was terminated on 11 March 2009 because the independent Data Monitoring Committee determined that the study had met its primary endpoint in demonstrating improvement in progression-free survival. The decision to terminate the trial was not based on safety concerns related to sunitinib administration.

Conditions

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Carcinoma, Islet Cell Carcinoma, Pancreas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

sunitinib malate

Intervention Type DRUG

* sunitinib malate oral starting dose 37.5 mg daily (continuous dosing).
* Dose may be decreased to 25 mg daily in case of adverse events.
* It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment.
* Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination.

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.

Interventions

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sunitinib malate

* sunitinib malate oral starting dose 37.5 mg daily (continuous dosing).
* Dose may be decreased to 25 mg daily in case of adverse events.
* It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment.
* Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination.

Intervention Type DRUG

Placebo

Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Well-differentiated advanced/metastatic pancreatic islet cell tumor
* Tumor has shown progression within the past year.

Exclusion Criteria

* Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent other than somatostatin analogues
* Prior treatment with any tyrosine kinase inhibitors or anti-VEGF\[Vascular endothelial growth factor\] angiogenic inhibitors.
* Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Aurora, Colorado, United States

Site Status

Pfizer Investigational Site

Iowa City, Iowa, United States

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Pfizer Investigational Site

Worcester, Massachusetts, United States

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Worcester, Massachusetts, United States

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Pfizer Investigational Site

City of Saint Peters, Missouri, United States

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Creve Coeur, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Georgetown, Texas, United States

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Norfolk, Virginia, United States

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Perth, Western Australia, Australia

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Brussels, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Paris, Be1 05677, France

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Paris, Cedex, France

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Clichy, France, France

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Bordeaux, , France

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Lyon, , France

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Marseille, , France

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Rennes, , France

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Bad Berka, , Germany

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Berlin, , Germany

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Heidelberg, , Germany

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Lübeck, , Germany

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Marburg, , Germany

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Ulm, , Germany

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Cremona, , Italy

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Milan, , Italy

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Rozzano (MI), , Italy

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Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Pfizer Investigational Site

Madrid, Madrid, Spain

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Pfizer Investigational Site

Madrid, Madrid, Spain

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Pfizer Investigational Site

Madrid, Madrid, Spain

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Pfizer Investigational Site

Kwei-Shan, Taoyuan, Taiwan

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Pfizer Investigational Site

Taipei, , Taiwan

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Pfizer Investigational Site

Leeds, , United Kingdom

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Pfizer Investigational Site

Liverpool, , United Kingdom

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Pfizer Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada France Germany Italy South Korea Spain Taiwan United Kingdom

References

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Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan;16(1):27-35. doi: 10.1007/s11523-020-00784-0. Epub 2021 Jan 7.

Reference Type DERIVED
PMID: 33411058 (View on PubMed)

Lamarca A, Barriuso J, Kulke M, Borbath I, Lenz HJ, Raoul JL, Meropol NJ, Lombard-Bohas C, Posey J, Faivre S, Raymond E, Valle JW. Determination of an optimal response cut-off able to predict progression-free survival in patients with well-differentiated advanced pancreatic neuroendocrine tumours treated with sunitinib: an alternative to the current RECIST-defined response. Br J Cancer. 2018 Jan;118(2):181-188. doi: 10.1038/bjc.2017.402. Epub 2017 Nov 21.

Reference Type DERIVED
PMID: 29161241 (View on PubMed)

Vinik A, Bottomley A, Korytowsky B, Bang YJ, Raoul JL, Valle JW, Metrakos P, Horsch D, Mundayat R, Reisman A, Wang Z, Chao RC, Raymond E. Patient-Reported Outcomes and Quality of Life with Sunitinib Versus Placebo for Pancreatic Neuroendocrine Tumors: Results From an International Phase III Trial. Target Oncol. 2016 Dec;11(6):815-824. doi: 10.1007/s11523-016-0462-5.

Reference Type DERIVED
PMID: 27924459 (View on PubMed)

Faivre S, Niccoli P, Castellano D, Valle JW, Hammel P, Raoul JL, Vinik A, Van Cutsem E, Bang YJ, Lee SH, Borbath I, Lombard-Bohas C, Metrakos P, Smith D, Chen JS, Ruszniewski P, Seitz JF, Patyna S, Lu DR, Ishak KJ, Raymond E. Sunitinib in pancreatic neuroendocrine tumors: updated progression-free survival and final overall survival from a phase III randomized study. Ann Oncol. 2017 Feb 1;28(2):339-343. doi: 10.1093/annonc/mdw561.

Reference Type DERIVED
PMID: 27836885 (View on PubMed)

Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Horsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. doi: 10.1056/NEJMoa1003825.

Reference Type DERIVED
PMID: 21306237 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181111&StudyName=A%20Study%20Of%20Sunitinib%20Compared%20To%20Placebo%20For%20Patients%20With%20Advanced%20Pancreatic%20Islet%20Cell%20Tumors

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6181111

Identifier Type: -

Identifier Source: org_study_id