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The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | Sunitinib capsule will be given orally at continuous daily dosing with a dose of 37.5 mg in the morning (regardless fasting or non-fasting, One cycle will be 28days) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Response Rate (CBR) | 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. | Up to 799 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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. | Up to 799 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center Central Hospital | Nagoya | Aichi-ken | Japan | |||
| Kyushu University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23269537 | Derived | Ito T, Okusaka T, Nishida T, Yamao K, Igarashi H, Morizane C, Kondo S, Mizuno N, Hara K, Sawaki A, Hashigaki S, Kimura N, Murakami M, Ohki E, Chao RC, Imamura M. Phase II study of sunitinib in Japanese patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumor. Invest New Drugs. 2013 Oct;31(5):1265-74. doi: 10.1007/s10637-012-9910-y. Epub 2012 Dec 27. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib | Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib | Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Benefit Response Rate (CBR) | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 799 days of treatment |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib | Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enterocolitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Tumor Shrinkage | Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants. | Up to 799 days of treatment |
| Progression-free Survival (PFS) | 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. | Up to 799 days of treatment |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause. | Up to 3 years from the last subject registration to the study |
| Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). | 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. | Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1 |
| Fukuoka |
| Fukuoka |
| Japan |
| Osaka Police Hospital | Osaka | Osaka | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | Japan |
| Sponsor Decision |
|
| Met study discontinuation criteria |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
|
|
| Secondary | Objective Response Rate (ORR) | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 799 days of treatment |
|
|
|
| Secondary | Tumor Shrinkage | Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants. | 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. | Posted | Mean | Standard Deviation | percent change | Up to 799 days of treatment |
|
|
|
| Secondary | Progression-free Survival (PFS) | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | Up to 799 days of treatment |
|
|
|
| Secondary | Overall Survival (OS) | Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause. | 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. | Posted | Median | 95% Confidence Interval | Months | Up to 3 years from the last subject registration to the study |
|
|
|
| Secondary | Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). | 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. | 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. | Posted | Mean | Standard Deviation | nanogram/mL | Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1 |
|
|
|
| 3 |
| 12 |
| 12 |
| 12 |
| Cholangitis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Eyelash discolouration | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Loose tooth | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Encephalitis herpes | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Infected epidermal cyst | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Trichophytosis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Scrotal haematocoele | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
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.
| D009380 | Neoplasms, Nerve Tissue |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
| Cycle 5 (n=9) |
|
| Cycle 7 (n=9) |
|
| Cycle 9 (n=9) |
|
| Cycle 11 (n=9) |
|
| Cycle 13 (n=9) |
|
| Cycle 14 (n=1) |
|
| Cycle 15 (n=7) |
|
| Cycle 16 (n=1) |
|
| Cycle 17 (n=5) |
|
| Cycle 18 (n=1) |
|
| Cycle 19 (n=4) |
|
| Cycle 21 (n=4) |
|
| Cycle 23 (n=4) |
|
| Cycle 25 (n=4) |
|
| Cycle 27 (n=3) |
|
| Cycle 28 (n=2) |
|
| Cycle 29 (n=1) |
|
| Maximum Reduction (n=12) |
|
|
| Sunitinib (Cycle 4 Day 1, n=5) |
|
| SU012662 (Cycle 1 Day 15, n=10) |
|
| SU012662 (Cycle 2 Day 1, n=2) |
|
| SU012662 (Cycle 3 Day 1, n=8) |
|
| SU012662 (Cycle 4 Day 1, n=5) |
|
| Total drug (Cycle 1 Day 15, n=10) |
|
| Total drug (Cycle 2 Day 1, n=2) |
|
| Total drug (Cycle 3 Day 1, n=8) |
|
| Total drug (Cycle 4 Day 1, n=5) |
|