oesophageal/gastric adenocarcinoma (which has relapsed in platinum pre-treated patients). MedDRA version: 9.1 Level: LLT Classification code 10062878 Term: Gastrooesophageal cancer
Conditions
Interventions
Trade Name: nexavar
Product Name: sorafenib
BAY 43-9006
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Sponsors
ICORG, the all-Ireland Co-operative Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Relapsed or progressed histologically confirmed oesophageal and/or gastric adenocarcinoma after prior platinum based chemotherapy not suitable for radical therapy. • Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug. • Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study drug. • Subjects with at least one uni-dimensional measurable lesion as assessed by the RECIST criteria. • Age > 18 years old. • ECOG Performance Status of 0 to 2. • Life expectancy of at least 2 months. • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose: - Haemoglobin > or = 9.0 g/dl. - Absolute neutrophil count (ANC) ³ 1.5 x 10^9/L. - Platelet count >or = 100 x 1^09/L. - Total bilirubin > 1.5 times the upper limit of normal. - ALT and AST =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Cardiac disease: History of cardiac disease: congestive heart failure >NYHA class 2; active Coronary Artery Disease (Mycardial Infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management. • Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. • Active clinically serious infections > or = CTCAE Grade 2. • Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months. • Pulmonary haemorrhage/bleeding event > or = CTCAE Grade 2 within 4 weeks of first dose of study drug. • Any other haemorrhage/bleeding event > or = CTCAE Grade 3 within 4 weeks of first dose of study drug. • Serious, non-healing wound, ulcer (apart from the tumour), or bone fracture. • Evidence or history of bleeding diathesis or coagulopathy. • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug. • Current signs or symptoms of severe progressive or uncontrolled hepatic, haematological, renal, endocrine, pulmonary or cardiac disease. • Uncontrolled, symptomatic brain metastases – intracranial bleeding into metastases with tyrosine kinase inhibitors (TKI's) appears to be rare in other solid tumours and in our view should not exclude patients with well controlled disease from the study. The patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies). • Previous treatment with a tyrosine kinase inhibitor or anti-angiogenic agent (licensed or investigational) such as sunitinib or bevacizumab. • Any previous drug treatment (licensed or investigational) that targets the RAS, VEGF, VEGFR or EGFR pathway. • Investigational drug therapy during or within 30 days. • Concomitant treatment with rifampin or St. John's Wort. • Any cancer chemotherapy, immunotherapy, radiotherapy or hormonal treatment over the previous 4 weeks. Palliative radiotherapy to symptomatic disease sites is permitted. • Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except bisphosphonates. • Women who are pregnant, nursing, or planning pregnancy within 6 months after the last treatment (this includes men who plan to father a child within 6 months of the last treatment). • Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin (1 mg p.o. qd) is permitted if the INR is 3 years prior to study entry. • Concurrent cancer that is distinct in primary site or histology from oesophago-gastric cancer. • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results. • Any condition that impairs patient’s ability to swallow w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the Disease Control rate after 4 months of treatment for each patient (complete response + partial response + stable disease) rate ;Secondary Objective: • Progression Free Survival • Overall Survival • Time to tumour progression • Objective response rate • Tolerability/ toxicity • Biomarkers of response/resistance to therapy ;Primary end point(s): Estimates of disease control rates (partial and complete responses, and stable disease sustained for =4 months as per RECIST guidelines, Appendix C of protocol) and their 95% confidence intervals will be calculated. | — |
Countries
Ireland
Outcome results
None listed