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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02359058 |
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Date of registration:
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04/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer
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Scientific title:
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Phase 1b Study of Ramucirumab in Combination With Fluoropyrimidines and Platinum-Based Agents in Japanese Patients With Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02359058 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Japan
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stomach Neoplasms
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Intervention(s)
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Drug: Oxaliplatin
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Drug: Ramucirumab
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Drug: S-1
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Drug: Capecitabine
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Drug: Cisplatin
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Primary Outcome(s)
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Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
[Time Frame: First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)]
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Secondary Outcome(s)
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
[Time Frame: First Dose to Date of Objective Progressive Disease or Death Due to Any Cause (Up To 22 Months)]
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Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab
[Time Frame: Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of Infusion]
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Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
[Time Frame: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 92 and Day 106: Pre-Dose]
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Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA)
[Time Frame: First dose to study completion plus 30-day safety follow-up (Up To 22 Months)]
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Secondary ID(s)
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15532
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I4T-JE-JVCX
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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