Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma

Inclusion Criteria:

- Pathologically confirmed adenocarcinoma of the esophagus, GEJ or stomach.

- Stage IV disease or locally advanced/unresectable tumors

- Prior progression on only 1 line of chemotherapy in the advanced/metastatic setting
containing a fluoropyrimidine and/or platinum compound

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion Criteria:

- Prior treatment with a taxane is not permitted in the dose-expansion phase. Patients
in the dose escalation component may have received a taxane in the peri-operative
setting, provided they developed disease recurrence >6 months after the completion of
this therapy

- Known pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C,
nonalcoholic steatohepatitis, sclerosing cholangitis)

- Patients with any clinically apparent ascites or who have undergone a paracentesis
within 7 days of enrollment

- Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm
Hg on repeated measurement) despite optimal medical management

- Active or clinically significant cardiac disease

- Patients with arterial thrombotic events, such as cerebrovascular accident or
myocardial infarction, within 6 months of enrollment