Patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors MedDRA version: 17.1 Level: LLT Classification code 10068916 Term: Pancreatic neuroendocrine tumor metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.1 Level: PT Classification code 10068909 Term: Pancreatic neuroendocrine tumour metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cyst
Conditions
Interventions
Product Name: Palbociclib
Product Code: PD0332991
Pharmaceutical Form: Capsule
INN or Proposed INN: NA
CAS Number: 571190-30-2
Current Sponsor code: PD-0332991
Other descriptive name: PALBOCICLIB
Conc
Sponsors
Grupo Español de Tumores Neuroendocrinos (GETNE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with Ki67 assessment of =65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy regimen or biological treatment for locally advanced or metastatic transitional cell carcinoma of the urinary tract. 2. Prior treatment on Cdk4 inhibitor under clinical trial. 3. Creatinine clearance 25% of the bone marrow. 8. Current treatment on another clinical trial. 9. Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months prior to first dose of treatment on study and should be asymptomatic. 10. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. 11. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus. 12. Ongoing cardiac dysrhythmias of NCI CTCAE grade ?2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 13. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy) 14. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). 15. Known human immunodeficiency virus infection. 16. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization. 17. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?Progression Free Survival (PFS) ?Time to Tumor Progression (TTP) ?Duration of response (DR) Overall survival (OS) ?Safety ?Biomarkers;Timepoint(s) of evaluation of this end point: Progression disease | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?Objective Response rate (ORR);Secondary Objective: ?Progression Free Survival (PFS) ?Time to Tumor Progression (TTP) ?Duration of response (DR) Overall survival (OS) ?Safety ?Biomarkers;Primary end point(s): Objective Response rate (ORR);Timepoint(s) of evaluation of this end point: Progression disease | — |
Countries
Spain
Contacts
Public ContactYolanda Martín
TFS
Outcome results
None listed