Clinical trial · Interventional
A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer
Phase 1b Study of Ramucirumab in Combination With Fluoropyrimidines and Platinum-Based Agents in Japanese Patients With Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
NCT02359058CI-TRIAL-00031356completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antitumor response of ramucirumab in combination with platinum/fluoropyrimidine regimens in Japanese participants with advanced gastric/gastrooesophageal junction cancer who have not received chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Ramucirumab | Drug | Ramucirumab | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Ramucirumab + Capecitabine + Cisplatin
- description
- Ramucirumab (8 milligram per kilogram (mg/kg) given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
- interventionNames
- Drug: Ramucirumab
- Drug: Capecitabine
- Drug: Cisplatin
- type
- OTHER
- label
- Ramucirumab + S-1 + Cisplatin
- description
- Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
- interventionNames
- Drug: Ramucirumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * A histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma which is metastatic or locally advanced and unresectable. A participant with esophageal cancer is not eligible. * Not have received prior first-line systemic chemotherapy for locally advanced and unresectable and/or metastatic disease. Participants whose disease has progressed after \>6 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible. * Measurable or nonmeasurable, but evaluable, disease, determined using guidelines in Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at the time of enrollment. * The participant has adequate organ function. * Resolution to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version \[v\]4.03) of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer. * Female participants of childbearing potential must have a negative serum or urinary pregnancy. Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator. Exclusion Criteria: * A significant bleeding disorder, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to enrollment. * Uncontrolled arterial hypertension, despite standard medical management. * A serious or nonhealing wound or peptic ulcer or bone fracture at enrollment. * Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device (reservoir) placement within 7 days prior to enrollment. * Radiation therapy within 14 days prior to enrollment. * Received any previous systemic therapy (including investigational agents) targeting vascular endothelial growth factor (VEGF) or the VEGF receptor signaling pathways. * Cirrhosis at a level of Child-Pugh B (or worse); or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. * A serious illness or medical condition(s). * Pregnant or breastfeeding. * Dysphagia for oral medication. * Known allergy or hypersensitivity to any study treatment. * Human epidermal growth factor receptor (HER) 2 status of positive. * Received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device.
References
Publications (0)
Data not yet available
No reference posted for this study.