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

NCT00428597

Last updated date
Study Location
Pfizer Investigational Site
Aurora, Colorado, 80045, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Islet Cell Carcinoma, Pancreas Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Well-differentiated advanced/metastatic pancreatic islet cell tumor

- Tumor has shown progression within the past year.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Islet Cell Carcinoma, Pancreas CarcinomaA Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors
NCT00428597
  1. Aurora, Colorado
  2. Iowa City, Iowa
  3. Worcester, Massachusetts
  4. Worcester, Massachusetts
  5. Creve Coeur, Missouri
  6. St. Louis, Missouri
  7. St. Louis, Missouri
  8. St. Peters, Missouri
  9. Austin, Texas
  10. Austin, Texas
  11. Austin, Texas
  12. Austin, Texas
  13. Georgetown, Texas
  14. Norfolk, Virginia
  15. Perth, Western Australia
  16. Bruxelles,
  17. Bruxelles,
  18. Leuven,
  19. Vancouver, British Columbia
  20. Halifax, Nova Scotia
  21. Halifax, Nova Scotia
  22. Halifax, Nova Scotia
  23. Toronto, Ontario
  24. Montreal, Quebec
  25. Montreal, Quebec
  26. Montreal, Quebec
  27. Paris, Be1 05677
  28. Paris, Cedex
  29. Bordeaux,
  30. Clichy Cedex,
  31. Lyon,
  32. Marseille,
  33. Rennes Cedex,
  34. Bad Berka,
  35. Berlin,
  36. Heidelberg,
  37. Luebeck,
  38. Marburg,
  39. Ulm,
  40. Cremona,
  41. Milano,
  42. Rozzano (MI),
  43. Seoul,
  44. Seoul,
  45. Barcelona,
  46. Barcelona,
  47. Madrid,
  48. Madrid,
  49. Madrid,
  50. Kwei-Shan, Taoyuan
  51. Taipei,
  52. Leeds,
  53. Liverpool,
  54. Manchester,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors
Official Title  ICMJE 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

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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Islet Cell
  • Carcinoma, Pancreas
Intervention  ICMJE
  • Drug: 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.
  • Drug: Placebo
    Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: sunitinib malate
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 14, 2009)
171
Original Enrollment  ICMJE
 (submitted: January 29, 2007)
340
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Korea, Republic of,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Colombia,   Denmark,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT00428597
Other Study ID Numbers  ICMJE A6181111
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP