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

Inclusion Criteria

* Histologically confirmed, unresectable, locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (Phase II). For the Phase Ib portion, any unresectable, locally advanced or metastatic solid tumor;
* ECOG PS of 0-1;
* Blood pressure must be well-controlled. Patients must have no history of hypertensive crisis or hypertensive encephalopathy; Adequate end organ function

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.