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A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01525550
First Posted: February 3, 2012
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: March 8, 2017  
Study Type: Interventional
Study Design: Masking: None (Open Label);   Primary Purpose: Other
Condition: Well-differentiated Pancreatic Neuroendocrine Tumor
Intervention: Drug: sunitinib

  Participant Flow
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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: Treatment Naive Cohort Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
Sunitinib: Later-Line Cohort Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).

Participant Flow:   Overall Study
    Sunitinib: Treatment Naive Cohort   Sunitinib: Later-Line Cohort
STARTED   61   45 
COMPLETED   0   0 
NOT COMPLETED   61   45 
Withdrawal by Subject                2                0 
Lost to Follow-up                4                1 
Death                10                19 
Other Unspecified                0                2 
Ongoing                45                23 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS) included all participants who were enrolled into the study regardless of whether participants received study drug or not.

Reporting Groups
  Description
Sunitinib: Treatment Naive Cohort Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
Sunitinib: Later-Line Cohort Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
Total Total of all reporting groups

Baseline Measures
   Sunitinib: Treatment Naive Cohort   Sunitinib: Later-Line Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   45   106 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.4  (8.9)   53.5  (9.1)   54.6  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      31  50.8%      12  26.7%      43  40.6% 
Male      30  49.2%      33  73.3%      63  59.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS): Investigator Assessment   [ Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days) ]

2.  Secondary:   Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment   [ Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days) ]

3.  Secondary:   Time to Tumor Progression (TTP): Investigator Assessment   [ Time Frame: Baseline until first documented tumor progression (up to 1226 days) ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline until death or study cut-off (up to 5 years) ]

5.  Secondary:   Percentage of Participants With Objective Response (OR): Investigator Assessment   [ Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days) ]

6.  Secondary:   Duration of Response (DOR): Investigator Assessment   [ Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days) ]

7.  Secondary:   Time to Tumor Response (TTR): Investigator Assessment   [ Time Frame: Baseline until first documented objective tumor response (up to 1226 days) ]

8.  Secondary:   Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment   [ Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days) ]

9.  Secondary:   Duration of Response (DOR): Independent Radiological Review (IRR) Assessment   [ Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days) ]

10.  Secondary:   Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment   [ Time Frame: Baseline until first documented objective tumor response (up to 1226 days) ]

11.  Secondary:   Percentage of Participants With Chromogranin A (CgA) Response   [ Time Frame: Baseline until CgA response or death due to any cause (up to 1226 days) ]

12.  Secondary:   Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)   [ Time Frame: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days) ]

13.  Secondary:   Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)   [ Time Frame: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days) ]

14.  Secondary:   Plasma Concentration of Soluble Protein Biomarker (sKIT)   [ Time Frame: Pre-dose on Day 1 and 15 of Cycle 1, Day 1 of Cycle 2, 3 and every 2 cycles thereafter (Cycle 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43), End of Treatment (up to 1226 days) ]

15.  Secondary:   Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662   [ Time Frame: Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 ]

16.  Secondary:   Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662   [ Time Frame: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 ]

17.  Secondary:   Area Under the Curve (AUC24) of Sunitinib and Its Metabolite SU012662   [ Time Frame: Pre-dose (0 hour) and at multiple time points (up to 24 hours) post dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days) ]

18.  Secondary:   Oral Clearance (CL/F) of Sunitinib and Its Metabolite SU012662   [ Time Frame: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days) ]

19.  Secondary:   Half Maximal Effective Concentration (EC50) of Sunitinib   [ Time Frame: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days) ]

20.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 1226 days ]

21.  Secondary:   Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 1226 days ]

22.  Secondary:   Number of Participants With Adverse Events (AEs) According to Severity   [ Time Frame: Baseline up to 1226 days ]

23.  Secondary:   Number of Participants With Clinically Significant Laboratory Abnormalities   [ Time Frame: Baseline up to 1226 days ]

24.  Secondary:   Number of Participants With Change From Baseline in Vital Signs Abnormalities   [ Time Frame: Baseline up to 1226 days ]

25.  Secondary:   Number of Participants With Increase From Baseline in Corrected QT Interval (QTc)   [ Time Frame: Baseline up to 1226 days ]

26.  Secondary:   Number of Participants With Change From Baseline in Physical Examinations Findings   [ Time Frame: Baseline up to 1226 days ]

27.  Secondary:   Number of Participants With Change From Baseline in Body Weight   [ Time Frame: Baseline up to 1226 days ]

28.  Secondary:   Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)   [ Time Frame: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01525550     History of Changes
Other Study ID Numbers: A6181202
2011-004363-74 ( EudraCT Number )
First Submitted: January 13, 2012
First Posted: February 3, 2012
Results First Submitted: March 8, 2017
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017