A PHASE III RANDOMIZED, DOUBLE-BLIND STUDY OF SUNITINIB (SU011248, SUTENT) VERSUS PLACEBO IN PATIENTS WITH PROGRESSIVE ADVANCED/METASTATIC WELL-DIFFERENTIATED PANCREATIC ISLET CELL TUMORS - ND
- Conditions
- Treatment of subjects with progressive advanced/metastatic well-differentiated pancreatic islet cell tumors.MedDRA version: 9.1Level: LLTClassification code 10025997Term: Malignant neoplasm of islets of Langerhans
- Registration Number
- EUCTR2006-004022-87-IT
- Lead Sponsor
- PFIZER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 340
1. Histologically or cytologically proven diagnosis of well-differentiated pancreatic islet cell tumor (according to WHO 2000 classification.) 2. Local, locally-advanced or metastatic disease documented as having shown progression on a scan (CT, MRI, or Octreoscan) taken within 2 to 12 months prior to baseline compared to a previous scan (taken at any time in the past). Progression must be documented according to RECIST guidelines. Octreoscan results may be used to document progressive disease prior to study entry, but not for RECIST determination of tumor response during the study. 3. Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent. 4. Presence of at least one measurable target lesion for further evaluation according to RECIST criteria (contrast enhancing lesion with the largest diameter >7= 20 mm, based on CT or MRI scan done within 3 weeks before the start of treatment). 5. 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]) /=3.0 g/dL ? Absolute neutrophil count (ANC) ?1500/mL ? Platelets >/=100,000/mL ? Hemoglobin >/=9.0 g/dL ? Serum creatinine /= 3 months. 8. Age >/= 18 years. 9. Previous treatments with chemotherapy, loco-regional therapy (e.g., chemoembolization) or interferon are permitted providing that toxicity has resolved to Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification19). 2. Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent other than somatostatin analogues. 3. Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted. 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 potent CYP3A4 inhibitors and inducers within 7 and 12 days, respectively prior to study drug administration 6. Pre-existing thyroid abnormality of thyroid function 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. Current treatment on another clinical trial. 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 >7=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