A Phase 2 Study of Ramucirumab in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First Line Platinum- or Fluoropyrimidine-Containing Combination Therapy in Japanese Patients
- Conditions
- Gastric Cancer
- Registration Number
- JPRN-jRCT2080222292
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma
- Metastatic disease or locally recurrent, unresectable disease
- Measurable disease and/or evaluable disease
- Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy
- Resolution to Grade less than or equal to 1 by the National Cancer Institute Common Terminology Criteria for Adverse , Version 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
- Eastern Cooperative Oncology Group performance status score of 0-1
- Has adequate organ function
- Must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods), if sexually active
- Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method