Gastric cancer MedDRA version: 12.1 Level: LLT Classification code 10017758 Term: Gastric cancer MedDRA version: 12.1 Level: LLT Classification code 10017760 Term: Gastric cancer NOS MedDRA version: 12.1 Level: LLT Classification code 10017766 Term: Gastric cancer stage IV NOS MedDRA version: 12.1 Level: LLT Classification code 10017767 Term: Gastric cancer stage IV with metastases MedDRA version: 12.1 Level: LLT Classification code 10017768 Term: Gastric cancer stage IV without metastases
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female or male aged 18 years or older 3. Histological or cytological confirmation of gastric adenocarcinoma (including the gastric cardia and esophagogastric junction) 4. Locally advanced or metastatic gastric cancer. In patients with locally advanced disease the cancer must be considered unresectable 5. Patients must have received no prior systemic therapy for advanced disease. Neoadjuvant and adjuvant therapy received > 6 months prior to entry into the study is acceptable 6. WHO Performance score of 0 or 1 7. Able to take oral medication 8. Life expectancy = 12 weeks 9. At least one lesion (measurable or non measurable) that can be accurately assessed by CT or MRI at baseline and follow-up visits. For inclusion in the optional genetic research and biomarker analysis components of the study (blood and archival tumour sampling for DNA extraction and retrospective pharmacogenetic analysis and tumour biomarker analysis), patients must fulfil the following criteria: 10. Provision of written informed consent for blood sampling for genetic research and/or 11. Provision of written informed consent for tumour biomarker analysis 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: 1.Untreated unstable brain or meningeal metastases. Patients with radiological evidence of stable brain metastases are eligible providing that they are asymptomatic and either do not require corticosteroids or have been treated with corticosteroids, with clinical and radiological evidence of stabilisation at least 10 days after discontinuation of steroids 2.Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count =1.5 x 10*9/L or platelet count =100 x 10*9/L or requiring regular blood transfusions to maintain haemoglobin >8.5g/dL 3.Serum bilirubin = 1.5 x ULRR (except for patients with known documented cases of Gilbert’s syndrome) 4.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5 x ULRR. If liver metastases are present, ALT or AST > 5 x ULRR 5.Serum creatinine > ULRR or a creatinine clearance of = 60mL/min calculated by Cockcroft-Gault 6.Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein 150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy (measurements will be made after the patient has been resting supine for a minimum of 5 minutes. Two or more readings should be taken at 2-minute intervals and averaged. If the first two diastolic readings differ by more than 5 mmHg, then an additional reading should be obtained and averaged) 8.Any evidence of severe or uncontrolled systemic diseases (eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 9.Any unresolved toxicity >CTC grade 1 from previous systemic anti-cancer therapy (including radiotherapy) except haematological toxicity (see exclusion #2) and alopecia 10.Mean QTc with Bazetts correction >470msec in screening ECG or history of familial long QT syndrome 11.Recent ( Grade 2 24.History of significant gastrointestinal impairment, as judged by the Investigator, that would
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of cediranib when added to cisplatin plus a fluoropyrimidine compared to cisplatin plus a fluoropyrimidine alone by assessment of overall survival (OS).;Secondary Objective: ·To determine the efficacy of cediranib when added to cisplatin plus a fluoropyrimidine compared to cisplatin plus a fluoropyrimidine alone by assessment of progression free survival (PFS), objective response rate and duration of response. ·To determine the safety and tolerability of cediranib when added to cisplatin plus a fluoropyrimidine compared to cisplatin plus a fluoropyrimidine alone. ·To determine the effects of cediranib when added to cisplatin plus a fluoropyrimidine compared to cisplatin plus a fluoropyrimidine alone on the global health status/QoL scale of the EORTC QLQ-C30 questionnaire. ·To investigate the pharmacokinetics of cediranib when added to cisplatin plus a fluoropyrimidine. ;Primary end point(s): Overall survival, defined as the time from randomisation until death by any cause. | — |
Countries
Greece, Hungary
Outcome results
None listed