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

NCT02359058 | Completed Phase 1 Results

• 2 other identifiers: 15532I4T-JE-JVCX
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

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

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

  First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)

Secondary Outcomes (4)

• Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab

  Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of Infusion

• Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab

  Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 92 and Day 106: Pre-Dose

• Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)

  First Dose to Date of Objective Progressive Disease or Death Due to Any Cause (Up To 22 Months)

• Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA)

  First dose to study completion plus 30-day safety follow-up (Up To 22 Months)

Study Arms (3)

Ramucirumab + Capecitabine + Cisplatin

OTHER

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.

Drug: Ramucirumab; Drug: Capecitabine; Drug: Cisplatin

Ramucirumab + S-1 + Cisplatin

OTHER

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.

Drug: Ramucirumab; Drug: Cisplatin; Drug: S-1

Ramucirumab + S-1 + Oxaliplatin

OTHER

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.

Drug: Ramucirumab; Drug: S-1; Drug: Oxaliplatin

Interventions

Ramucirumab DRUG

Administered IV

Also known as: LY3009806, IMC-1121B

Ramucirumab + Capecitabine + Cisplatin; Ramucirumab + S-1 + Cisplatin; Ramucirumab + S-1 + Oxaliplatin

Capecitabine DRUG

Administered orally

Ramucirumab + Capecitabine + Cisplatin

Cisplatin DRUG

Administered IV

Ramucirumab + Capecitabine + Cisplatin; Ramucirumab + S-1 + Cisplatin

S-1 DRUG

Administered orally

Ramucirumab + S-1 + Cisplatin; Ramucirumab + S-1 + Oxaliplatin

Oxaliplatin DRUG

Administered IV

Ramucirumab + S-1 + Oxaliplatin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.

Aichi, 464-8681, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.

Chiba, 277-8577, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.

Ehime, 791-0280, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician

Osaka, 565-0871, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Ramucirumab; Capecitabine; Cisplatin; S 1 (combination); Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 9, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 24, 2018
• Results First Posted: December 4, 2017

Record last verified: 2017-07

Locations

JP (4)