A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer
Primary
Inclusion Criteria:
- At least 20 years of age
- Histologically or cytologically confirmed gastric carcinoma, including gastric or
gastroesophageal-junction adenocarcinoma.
- Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable
disease
- Previously untreated, unresectable advanced (M0) or unresectable metastatic (M1)
disease except for prior adjuvant (or neo-adjuvant) chemotherapy.
- ECOG performance status 0 or 1
- At least 4 weeks and recovery from effects of prior major surgery
- Adequate bone marrow, hepatic, and renal function
Primary Exclusion Criteria:
- Operable gastric or gastroesophageal-junction cancer
- Known brain metastasis
- Second cancer
- Previous adjuvant or neo-adjuvant chemotherapy with capecitabine and cisplatin in
combination. (Previous adjuvant or neo-adjuvant monotherapy with capecitabine or S-1
or therapy with S-1 and cisplatin in combination or 5-FU and cisplatin in combination
is allowed.)
- Uncontrolled diarrhea
- Nausea or vomiting for at least 3 consecutive days within the 14 days prior to
registration despite the administration of standard antiemetic therapy
- Symptomatic peripheral neuropathy ≥ Grade 2
- Malabsorption syndrome or other disease that significantly affects gastrointestinal
function
- Other uncontrolled systemic illness