Efficacy and Safety of Sunitinib in Patients with Advanced Well-differentiated Pancreatic Neuroendocrine Tumors
- Conditions
- progressive advanced metastatic well differentiated unresectable pancreatic neuroendocrine tumorsMedDRA version: 14.1Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004363-74-IT
- Lead Sponsor
- PFIZER INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 106
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumor (according to WHO 2000 classification) with available Ki-67 index. 4. Unresectable (as assessed by the investigator) or metastatic disease documented on a scan (CT, MRI, or Octreoscan) taken within 28 days of study enrollment. Disease progression (per RECIST 1.0) within 12 months prior to study enrollment. 5. Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent. 6. Presence of at least one measurable target lesion for further evaluation according to RECIST 1.0 (contrast enhancing lesion with the largest diameter =20 mm, based on conventional CT scan (or =10 mm with spiral CT scan) done within 3 weeks before the start of treatment). 7. Adequate organ function as defined by the following: ? Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) ?2.5 x upper limit of normal (ULN). If liver function abnormalities are due to liver metastases, then AST and ALT may be =5 x ULN; ? Total serum bilirubin =1.5 x ULN; ? Absolute neutrophil count (ANC) =1500/µL; ? Platelets =100,000/µL; ? Hemoglobin =9.0 g/dL. 8. ECOG Performance status 0 or 1. 9. Life expectancy =3 months. 10. Age =18 years. 11. Able to swallow oral compound. 12. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 3 months after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1.Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. 2. Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification). 3. Prior treatment with any tyrosine kinase inhibitors, anti-VEGF angiogenesis inhibitors, non-VEGF-targeted angiogenesis inhibitors, or mTOR inhibitors. 4. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri. 5. Treatment with strong CYP3A4 inhibitors and inducers within 7 and 12 days, respectively, prior to study drug administration. 6. Pre-existing abnormality of thyroid function with TSH that cannot be maintained in the normal range with medication. 7. Concomitant treatment with therapeutic doses of anticoagulants. Low dose warfarin (Coumadin) up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed. 8. Unstable systemic diseases including uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy) or active uncontrolled infections. 9. Participation in other studies within 4 weeks before baseline scans (ie, screening) before the current study begins and/or during study participation. 10. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. 11. Abnormal cardiac function with abnormal 12-lead ECG. Ongoing cardiac dysrhythmias of NCI CTC grade ?2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females. 12. Symptomatic brain metastases, spinal cord compression, or new evidence of brain or leptomeningeal disease. 13. Left ventricular ejection fraction (LVEF)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method