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A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Advanced Gastric Cancer

Thank you

Trial Information

A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer

Inclusion Criteria:

- Having given signed written informed consent

- Unresectable advanced gastric adenocarcinoma, initially diagnosed or recurred

- No history of chemotherapy or radiation

- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)

- Age 18-75 years

- Estimated life expectancy of more than 3 months

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Adequate bone marrow function (absolute neutrophil count > 1,500/µL, platelets >
100,000/µL, hemoglobin > 8g/dl),

- Adequate kidney function (creatinine clearance > 60 ml/min)

- Adequate liver function (bilirubin < 2.0 mg/dL, transaminases levels < 3 times the
upper normal limit [5 times for patients with liver metastasis])

Exclusion Criteria:

- Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for
curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study treatment start

- Presence of central nervous system metastasis

- Obvious peritoneal seeding or bowel obstruction

- Evidence of serious gastrointestinal bleeding

- Peripheral neuropathy (National Cancer Institute Common Terminology Criteria for
Adverse Event version 3.0 > Grade I)

- History of significant neurologic or psychiatric disorders

- Pregnant or lactating women, women of childbearing potential not employing adequate

- Other serious illness or medical conditions

- Known allergy to study drugs

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose for phase I portion

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

Yoon-Koo Kang, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Asan Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

December 2009

Related Keywords:

  • Advanced Gastric Cancer
  • Gastric cancer
  • capecitabine
  • cisplatin
  • sorafenib
  • phase I
  • phase II
  • Stomach Neoplasms