Pancreatic cancer patients who failed first line therapy with gemcitabine MedDRA version: 9.1 Level: LLT Classification code 10033604 Term: Pancreatic cancer
Conditions
Interventions
Trade Name: Tyverb
Product Name: Lapatinib
Product Code: GW572016
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LAPATINIB
CAS Number: 61825943
Concentration unit: mg milligram(s)
Concen
Sponsors
Charite Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven pancreatic adenocarcinoma - Metastatic disease (phase 2 only) - Karnowski PI>60 - No other therapy for metastatic pancreatic cancer than Gemcitabine - Time of progression on Gemcitabine not earlier than 4 weeks before inclusion - Measurable disease according to RECIST criteria. - Normal cardiac function demonstrated by ECG and echocardiogram (LVEF = 55%) - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - Adequate organ function as defined by laboratory values Hematologic ANC (absolute neutrophil count) => 1,5 x 109/L Hemoglobin => 10 g/dL Platelets => 100 x 109/L Hepatic Albumin =>2.5 g/dL Serum bilirubin =60 mL/min (Calculated by the Cockcroft and Gault Method) - Patient has provided written informed consent. - compliance 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
Exclusion criteria
Exclusion criteria: - Insufficient renal/hepatic/bone marrow function - prior radiation - prior erlotinib therapy - secondary malignancies except for basal cell carcinoma of the skin during the last 5 years - concomittant diseases which would, to the opinion of the investigator, endanger study participation - pregnancy . - Class II, III or IV heart failure as defined by the NYHA functional classification system. Myocardial infarction, unstable angina, cardiac angioplasty or stenting procedure within the last 6 months - arterial or venous thrombosis, including stroke, transient ischemic attack, or cerebrovascular accident [CVA] within the last 6 months - History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism or excretion of study drugs. Subjects with ulcerative colitis or an unresolved bowel obstruction are also excluded. - Concurrent disease or condition that would make the subject inappropriate for study participation or would interfere with the subject’s safety. - Any psychological, familial, or sociological conditions that do not permit compliance with the protocol. - Requirement of concurrent cancer therapy (chemotherapy, radiation therapy, biologic therapy, immunotherapy, or hormonal therapy) while on study. - Requirement of concurrent treatment with an investigational agent, participation in another clinical trial, or any specifically prohibited medication while on study. - known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Oxaliplatin, 5-FU, Folinic acid or lapatinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1: MTD of Tyverb in combination with oxaliplatin, 5-FU and Folinic acid Phase 2: Rate of patients with progressive disease after 12 weeks;Secondary Objective: Toxicity, median survival, progression free survival and response rate;Primary end point(s): PhaseI Study Primary endpoint Find the optimal dose of lapatinib in combination with Oxaliplatin/5-FU/Folinic acid (OFF) Phase II Study Primary endpoint: Rate of progressive disease after 12 weeks | — |
Countries
Germany
Outcome results
None listed