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Trial record 51 of 2730 for:    Neuroendocrine Tumors | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT01121562
Recruitment Status : Completed
First Posted : May 12, 2010
Results First Posted : August 27, 2012
Last Update Posted : June 30, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Neuroendocrine Tumors
Intervention Drug: Sunitinib
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib
Hide Arm/Group Description Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Period Title: Overall Study
Started 12
Completed 0
Not Completed 12
Reason Not Completed
Objective progression or relapse             8
Withdrawal by Subject             1
Adverse Event             1
Sponsor Decision             1
Met study discontinuation criteria             1
Arm/Group Title Sunitinib
Hide Arm/Group Description Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
54.1  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
1.Primary Outcome
Title Clinical Benefit Response Rate (CBR)
Hide Description

CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks.

Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started.

Time Frame Up to 799 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.0
(42.8 to 94.5)
2.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR is defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.
Time Frame Up to 799 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(21.1 to 78.9)
3.Secondary Outcome
Title Tumor Shrinkage
Hide Description Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.
Time Frame Up to 799 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication. "n " in the measured values means number of participants analyzed in the cycle.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percent change
Cycle 1 (n=1) -20.0 [1]   (NA)
Cycle 2 (n=11) -14.4  (13.43)
Cycle 3 (n=12) -18.0  (17.70)
Cycle 5 (n=9) -26.0  (10.03)
Cycle 7 (n=9) -28.5  (11.86)
Cycle 9 (n=9) -31.8  (17.20)
Cycle 11 (n=9) -36.4  (30.11)
Cycle 13 (n=9) -28.8  (16.92)
Cycle 14 (n=1) 1.7 [1]   (NA)
Cycle 15 (n=7) -32.5  (17.29)
Cycle 16 (n=1) -34.7 [1]   (NA)
Cycle 17 (n=5) -38.7  (15.41)
Cycle 18 (n=1) -43.1 [1]   (NA)
Cycle 19 (n=4) -37.8  (19.21)
Cycle 21 (n=4) -35.8  (19.19)
Cycle 23 (n=4) -35.1  (22.82)
Cycle 25 (n=4) -32.6  (19.64)
Cycle 27 (n=3) -30.8  (26.68)
Cycle 28 (n=2) -40.4  (9.72)
Cycle 29 (n=1) 3.3 [1]   (NA)
Maximum Reduction (n=12) -34.8  (28.76)
[1]
Only 1 participant was analyzed in this cycle
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is defined as the time from registration to first documentation of progressive disease (PD) or to death due to any cause, whichever occurs first.
Time Frame Up to 799 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.

Median PFS had not yet been reached due to short of events.

Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: Months
16.8
(9.3 to 26.2)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.
Time Frame Up to 3 years from the last subject registration to the study
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.

OS was not analyzed due to short of events.

Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(22.0 to NA)
[1]
Median OS had not yet been reached due to short of events.
6.Secondary Outcome
Title Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).
Hide Description

Reference dose is 37.5 mg. Dose-corrected concentration is calculated from the following formula, "observed concentration multiplied by 37.5" over "actual dose".

SU012662 is an active metabolite of sunitinib.

Time Frame Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetics analysis set was defined as all participants who had at least one plasma concentration data at trough sampling with steady-state condition. "n" in the measured values means number of participants analyzed.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: nanogram/mL
Sunitinib (Cycle 1 Day 15, n=10) 53.9  (17.6)
Sunitinib (Cycle 2 Day 1, n=2) 41.7  (21.9)
Sunitinib (Cycle 3 Day 1, n=8) 49.9  (19.7)
Sunitinib (Cycle 4 Day 1, n=5) 53.5  (24.6)
SU012662 (Cycle 1 Day 15, n=10) 23.7  (7.00)
SU012662 (Cycle 2 Day 1, n=2) 21.2  (6.36)
SU012662 (Cycle 3 Day 1, n=8) 25.7  (9.14)
SU012662 (Cycle 4 Day 1, n=5) 19.6  (7.44)
Total drug (Cycle 1 Day 15, n=10) 77.5  (20.9)
Total drug (Cycle 2 Day 1, n=2) 62.9  (28.3)
Total drug (Cycle 3 Day 1, n=8) 75.5  (26.5)
Total drug (Cycle 4 Day 1, n=5) 73.0  (28.8)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Sunitinib
Hide Arm/Group Description Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
All-Cause Mortality
Sunitinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib
Affected / at Risk (%)
Total   3/12 (25.00%) 
Gastrointestinal disorders   
Enterocolitis * 1  1/12 (8.33%) 
Hepatobiliary disorders   
Cholangitis * 1  1/12 (8.33%) 
Cholecystitis acute * 1  1/12 (8.33%) 
Nervous system disorders   
Convulsion * 1  1/12 (8.33%) 
Loss of consciousness * 1  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib
Affected / at Risk (%)
Total   12/12 (100.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  2/12 (16.67%) 
Disseminated intravascular coagulation * 1  1/12 (8.33%) 
Neutropenia * 1  2/12 (16.67%) 
Thrombocytopenia * 1  1/12 (8.33%) 
Cardiac disorders   
Left ventricular dysfunction * 1  2/12 (16.67%) 
Endocrine disorders   
Hypothyroidism * 1  4/12 (33.33%) 
Eye disorders   
Conjunctival haemorrhage * 1  1/12 (8.33%) 
Diplopia * 1  1/12 (8.33%) 
Eyelash discolouration * 1  1/12 (8.33%) 
Ocular hyperaemia * 1  1/12 (8.33%) 
Gastrointestinal disorders   
Abdominal distension * 1  1/12 (8.33%) 
Abdominal pain * 1  1/12 (8.33%) 
Ascites * 1  2/12 (16.67%) 
Constipation * 1  1/12 (8.33%) 
Diarrhoea * 1  10/12 (83.33%) 
Dyspepsia * 1  1/12 (8.33%) 
Dysphagia * 1  1/12 (8.33%) 
Gastritis * 1  1/12 (8.33%) 
Gingivitis * 1  2/12 (16.67%) 
Glossitis * 1  1/12 (8.33%) 
Haemorrhoids * 1  1/12 (8.33%) 
Hypoaesthesia oral * 1  1/12 (8.33%) 
Loose tooth * 1  1/12 (8.33%) 
Nausea * 1  5/12 (41.67%) 
Oral dysaesthesia * 1  2/12 (16.67%) 
Periodontitis * 1  1/12 (8.33%) 
Reflux oesophagitis * 1  2/12 (16.67%) 
Stomatitis * 1  2/12 (16.67%) 
Toothache * 1  1/12 (8.33%) 
Vomiting * 1  5/12 (41.67%) 
General disorders   
Face oedema * 1  1/12 (8.33%) 
Fatigue * 1  7/12 (58.33%) 
Malaise * 1  2/12 (16.67%) 
Mucosal inflammation * 1  3/12 (25.00%) 
Oedema * 1  4/12 (33.33%) 
Oedema peripheral * 1  2/12 (16.67%) 
Pyrexia * 1  5/12 (41.67%) 
Hepatobiliary disorders   
Cholangitis * 1  1/12 (8.33%) 
Hepatic failure * 1  1/12 (8.33%) 
Infections and infestations   
Encephalitis herpes * 1  1/12 (8.33%) 
Enteritis infectious * 1  1/12 (8.33%) 
Enterocolitis infectious * 1  1/12 (8.33%) 
Hordeolum * 1  1/12 (8.33%) 
Infected epidermal cyst * 1  1/12 (8.33%) 
Nasopharyngitis * 1  5/12 (41.67%) 
Oral herpes * 1  1/12 (8.33%) 
Pharyngitis * 1  1/12 (8.33%) 
Pneumonia * 1  1/12 (8.33%) 
Pyoderma * 1  1/12 (8.33%) 
Skin candida * 1  1/12 (8.33%) 
Trichophytosis * 1  2/12 (16.67%) 
Injury, poisoning and procedural complications   
Contusion * 1  2/12 (16.67%) 
Fall * 1  1/12 (8.33%) 
Wound * 1  1/12 (8.33%) 
Investigations   
Blood alkaline phosphatase increased * 1  1/12 (8.33%) 
Blood urine present * 1  1/12 (8.33%) 
Electrocardiogram QT prolonged * 1  3/12 (25.00%) 
Gamma-glutamyltransferase increased * 1  1/12 (8.33%) 
Lipase increased * 1  2/12 (16.67%) 
Lymphocyte count decreased * 1  1/12 (8.33%) 
Neutrophil count decreased * 1  4/12 (33.33%) 
Platelet count decreased * 1  2/12 (16.67%) 
Protein urine present * 1  2/12 (16.67%) 
Urine output decreased * 1  1/12 (8.33%) 
White blood cell count decreased * 1  3/12 (25.00%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  4/12 (33.33%) 
Hyperamylasaemia * 1  1/12 (8.33%) 
Hypercholesterolaemia * 1  1/12 (8.33%) 
Hypoalbuminaemia * 1  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/12 (8.33%) 
Back pain * 1  2/12 (16.67%) 
Muscle spasms * 1  3/12 (25.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma * 1  1/12 (8.33%) 
Nervous system disorders   
Dysaesthesia * 1  1/12 (8.33%) 
Dysgeusia * 1  5/12 (41.67%) 
Headache * 1  7/12 (58.33%) 
Hypoaesthesia * 1  1/12 (8.33%) 
Psychiatric disorders   
Insomnia * 1  1/12 (8.33%) 
Renal and urinary disorders   
Haematuria * 1  1/12 (8.33%) 
Nephrotic syndrome * 1  1/12 (8.33%) 
Pollakiuria * 1  1/12 (8.33%) 
Proteinuria * 1  2/12 (16.67%) 
Reproductive system and breast disorders   
Scrotal haematocoele * 1  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/12 (8.33%) 
Epistaxis * 1  2/12 (16.67%) 
Pleural effusion * 1  1/12 (8.33%) 
Pneumomediastinum * 1  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
Dermatitis acneiform * 1  1/12 (8.33%) 
Dry skin * 1  1/12 (8.33%) 
Eczema * 1  1/12 (8.33%) 
Hair colour changes * 1  1/12 (8.33%) 
Nail disorder * 1  1/12 (8.33%) 
Onychomadesis * 1  1/12 (8.33%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  8/12 (66.67%) 
Pruritus * 1  2/12 (16.67%) 
Rash * 1  2/12 (16.67%) 
Skin discolouration * 1  1/12 (8.33%) 
Skin reaction * 1  1/12 (8.33%) 
Vascular disorders   
Hypertension * 1  8/12 (66.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01121562     History of Changes
Other Study ID Numbers: A6181193
First Submitted: May 10, 2010
First Posted: May 12, 2010
Results First Submitted: July 1, 2012
Results First Posted: August 27, 2012
Last Update Posted: June 30, 2014