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

NCT00428597 | Terminated Phase 3 Results DMC

• 1 other identifier: A6181111
• Study Type: interventional
• Target: 171
• Locations: 11 countries
• Sites: 54

Brief 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.

Conditions

Carcinoma, Islet Cell; Carcinoma, Pancreas

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  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.

  From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death

Secondary Outcomes (19)

• Number of Subjects With Objective Response

  From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter

• Duration of Response (DR)

  From start of treatment through Day 1 of Week 5, 9, and every 8 weeks thereafter until disease progression or death due to any cause

• Time-to-Tumor Response (TTR)

  From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter

• Overall Survival (OS)

  From start of study treatment up to 22 months

• European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale

  Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal

Study Arms (2)

A

EXPERIMENTAL

Drug: sunitinib malate

B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

sunitinib malate 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.

A

Placebo DRUG

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (54)

Pfizer Investigational Site

Aurora, Colorado, 80045, United States

Location

Pfizer Investigational Site

Iowa City, Iowa, 52242, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, 01605, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, 01655, United States

Location

Pfizer Investigational Site

City of Saint Peters, Missouri, 63376, United States

Location

Pfizer Investigational Site

Creve Coeur, Missouri, 63141, United States

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Pfizer Investigational Site

St Louis, Missouri, 63110-1094, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Austin, Texas, 78745, United States

Location

Pfizer Investigational Site

Austin, Texas, 78758, United States

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Pfizer Investigational Site

Austin, Texas, 78759, United States

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Pfizer Investigational Site

Georgetown, Texas, 78626, United States

Location

Pfizer Investigational Site

Norfolk, Virginia, 23510, United States

Location

Pfizer Investigational Site

Perth, Western Australia, 6000, Australia

Location

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Pfizer Investigational Site

Brussels, 1200, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5G 2M9, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2X 3J4, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3A 1A1, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

Pfizer Investigational Site

Paris, Be1 05677, 75571, France

Location

Pfizer Investigational Site

Paris, Cedex, 75679, France

Location

Pfizer Investigational Site

Clichy, France, 92118, France

Location

Pfizer Investigational Site

Bordeaux, 33000, France

Location

Pfizer Investigational Site

Lyon, 69003, France

Location

Pfizer Investigational Site

Marseille, 13385, France

Location

Pfizer Investigational Site

Rennes, 35062, France

Location

Pfizer Investigational Site

Bad Berka, 99437, Germany

Location

Pfizer Investigational Site

Berlin, 13353, Germany

Location

Pfizer Investigational Site

Heidelberg, 69120, Germany

Location

Pfizer Investigational Site

Lübeck, 23538, Germany

Location

Pfizer Investigational Site

Marburg, 35043, Germany

Location

Pfizer Investigational Site

Ulm, 89081, Germany

Location

Pfizer Investigational Site

Cremona, 26100, Italy

Location

Pfizer Investigational Site

Milan, 20141, Italy

Location

Pfizer Investigational Site

Rozzano (MI), 20089, Italy

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08025, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28007, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28041, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28046, Spain

Location

Pfizer Investigational Site

Kwei-Shan, Taoyuan, 333, Taiwan

Location

Pfizer Investigational Site

Taipei, 100, Taiwan

Location

Pfizer Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

Pfizer Investigational Site

Liverpool, L69 3GA, United Kingdom

Location

Pfizer Investigational Site

Manchester, M20 4BX, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 33411058 DERIVED

• 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.

  PMID: 29161241 DERIVED

• 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.

  PMID: 27924459 DERIVED

• 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.

  PMID: 27836885 DERIVED

• 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.

  PMID: 21306237 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Islet Cell; Pancreatic Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 30, 2007
• Study Start: June 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 11, 2010
• Results First Posted: October 11, 2010

Record last verified: 2010-09

Locations

KR (2); CA (8); GB (3); BE (3); IT (3); ES (5); US (14); AU (1); DE (6); TW (2); FR (7)