E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer

Exclusion Criteria

• •Gastric cancer patients who have had a complete gastrectomy;
• •Patients with known HER2 over-expressing advanced or metastatic gastric cancer;
• •Previously received E7050, its chemical derivatives, anti-cMet, anti-angiogenic therapy, (prior anti-angiogenic therapy is permitted in Phase Ib only).
• •For Phase Ib prior systemic therapy is allowed as long as PS and end organ function meet entry criteria;
• •For Phase II no prior palliative chemotherapy is permitted. Adjuvant/neoadjuvant chemotherapy is permitted if less than 12 months have elapsed between the end of adjuvant/neoadjuvant therapy and first recurrence;
• •Known central nervous system lesions, except for asymptomatic non-progressing, treated brain metastases. Treatment for brain mets, but have been completed at least 4 weeks prior to Day 1
• •Palliative radiotherapy is not permitted throughout the study period. Prior palliative radiotherapy within 30 days prior to commencing study treatment;
• •Clinically significant hemoptysis;
• •Patients with known dihydropyrimidine dehydrogenase deficiency;
• •Patients with clinically significant hearing loss that may be further diminished by treatment with cisplatin plus capecitabine (significance of hearing loss to be determined by the Investigator;
• •Serious non-healing wound, ulcer, or active bone fracture;
• •Major surgical procedure, open biopsy, or significant traumatic injury within the 21 days prior to commencing study treatment;
• •Clinically significant gastrointestinal bleeding within 6 months prior to first dose.