A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer

Lilly

Status and phase: Completed; Phase 1

Conditions: Stomach Neoplasms

Treatments: Drug: Capecitabine; Drug: Cisplatin; Drug: S-1; Drug: Ramucirumab; Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02359058

I4T-JE-JVCX (Other Identifier)

15532

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Ramucirumab + Capecitabine + Cisplatin

Other group

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.

Treatment:

Drug: Ramucirumab

Drug: Capecitabine

Drug: Cisplatin

Ramucirumab + S-1 + Cisplatin

Other group

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.

Treatment:

Drug: Ramucirumab

Drug: S-1

Drug: Cisplatin

Ramucirumab + S-1 + Oxaliplatin

Other group

Description:

Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Treatment:

Drug: Oxaliplatin

Drug: Ramucirumab

Drug: S-1