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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Carcinoma, Islet Cell Carcinoma, Pancreas
Interventions:	Drug: sunitinib malate Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Sunitinib	Oral sunitinib 37.5 milligrams (mg) once daily on a continuous daily dosing schedule.
Placebo	Matching placebo.

Participant Flow: Overall Study

	Sunitinib	Placebo
STARTED	86	85
Received Treatment	83	82
COMPLETED	0	0
NOT COMPLETED	86	85
Randomized but not treated	3	3
Objective Progression or Relapse	19	47
Study Terminated by Sponsor	41	16
Adverse Event	15	7
Global Deterioration of Health Status	1	5
Protocol Violation	2	1
Withdrawal by Subject	2	1
Unknown	1	1
Lost to Follow-up	0	1
Pregnancy	1	0
Death	1	3

Baseline Characteristics

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Reporting Groups

	Description
Sunitinib	Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Placebo	Matching placebo.

Baseline Measures

	Sunitinib	Placebo	Total
Number of Participants [units: participants]	86	85	171
Age, Customized [units: participants]
Between 18 and 44 years	19	17	36
Between 45 and 64	45	45	90
>=65 years	22	23	45
Gender [units: participants]
Female	44	45	89
Male	42	40	82

Outcome Measures

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1. Primary:

Progression Free Survival (PFS) [ Time Frame: From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death ]

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2. Secondary:

Number of Subjects With Objective Response [ Time Frame: From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter ]

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3. Secondary:

Duration of Response (DR) [ Time Frame: 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 ]

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4. Secondary:

Time-to-Tumor Response (TTR) [ Time Frame: From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter ]

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5. Secondary:

Overall Survival (OS) [ Time Frame: From start of study treatment up to 22 months ]

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6. Secondary:

European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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7. Secondary:

EORTC QLQ-C30 - Cognitive Functioning Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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8. Secondary:

EORTC QLQ-C30 - Emotional Functioning Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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9. Secondary:

EORTC QLQ-C30 - Physical Functioning Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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10. Secondary:

EORTC QLQ-C30 - Role Functioning Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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11. Secondary:

EORTC QLQ-C30 - Social Functioning Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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12. Secondary:

EORTC QLQ-C30 - Appetite Loss Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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13. Secondary:

EORTC QLQ-C30 - Constipation Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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14. Secondary:

EORTC QLQ-C30 - Diarrhea Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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15. Secondary:

EORTC QLQ-C30 - Dyspnea Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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16. Secondary:

EORTC QLQ-C30 - Fatigue Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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17. Secondary:

EORTC QLQ-C30 - Financial Difficulties Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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18. Secondary:

EORTC QLQ-C30 - Insomnia Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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19. Secondary:

EORTC QLQ-C30 - Nausea and Vomiting Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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20. Secondary:

EORTC QLQ-C30 - Pain Subscale [ Time Frame: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided by Pfizer

Publications automatically indexed to this study:

Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Hörsch 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.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00428597 History of Changes
Other Study ID Numbers:	A6181111
Study First Received:	January 29, 2007
Results First Received:	April 15, 2010
Last Updated:	September 16, 2010
Health Authority:	United States: Food and Drug Administration