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A Phase 2 Study of Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Junction (GEJ) Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02443883
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : March 13, 2018
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study was to evaluate the safety and pharmacokinetics of administering various dose regimens of ramucirumab in participants with advanced gastric cancer whose disease has progressed during or following prior chemotherapy.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Drug: Ramucirumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Trial Evaluating Pharmacokinetics and Safety of Four Ramucirumab Dosing Regimens in Second-Line Gastric or Gastroesophageal Junction Adenocarcinoma
Actual Study Start Date : July 7, 2015
Actual Primary Completion Date : November 18, 2016
Actual Study Completion Date : June 5, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ramucirumab

Arm Intervention/treatment
Experimental: Ramucirumab Regimen 1
Standard dose of 8 milligram per kilogram (mg/kg) ramucirumab given intravenously (IV) on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B

Experimental: Ramucirumab Regimen 2
Experimental dose of 12 mg/kg ramucirumab given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B

Experimental: Ramucirumab Regimen 3
Experimental dose of 6 mg/kg ramucirumab given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B

Experimental: Ramucirumab Regimen 4
Experimental dose of 8 mg/kg ramucirumab given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Day 29, 43, 71 and 85: predose ]
    The Cmin is the minimum observed serum concentration of ramucirumab.


Secondary Outcome Measures :
  1. Immunogenicity: Number of Participants With Anti-Ramucirumab Antibodies [ Time Frame: Predose Cycle 1 Through Short Term Follow Up (Up to 5 Months) ]
    Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline.

  2. Rate of Progression Free Survival (PFS) at the First 6-Week Tumor Assessment [ Time Frame: Baseline until the first 6-week tumor assessment ]
    PFS defined as the time from first day of therapy to first evidence of disease progression per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) or death from any cause up to the first 6-week tumor assessment. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study and absolute increase of at least 5 mm.Appearance of 1 or more new lesions was also considered progression. Nontarget PD is unequivocal progression of existing nontarget lesions.Appearance of 1 or more new nontarget lesions was also considered PD.Participants with no baseline disease assessment: PFS time was censored at the randomization date,regardless of whether or not objectively determined disease progression or death has been observed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ).
  • The participant has documented disease progression during or within 4 months after the last dose of first-line chemotherapy for metastatic disease, or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
  • The participant received combination chemotherapy prior to disease progression.

    • Prior chemotherapy regimens must include a platinum and/or a fluoropyrimidine component and must not include a taxane or antiangiogenic agent.
  • The participant has metastatic disease or locally advanced disease that is measurable or nonmeasurable, but is evaluable disease by radiological imaging per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
  • Patients are eligible if they are considered not appropriate, for whatever reason, for treatment with ramucirumab in combination with paclitaxel.
  • The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • The participant has adequate organ function, including:

    • Total bilirubin 1.5 × the upper limit of institutional normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 × ULN. If the liver has tumor involvement, AST and ALT <5 × ULN are acceptable.
    • Serum creatinine 1.5 × ULN or calculated creatinine clearance (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection) 60 milliliters/minute (mL/min).
    • Urinary protein is <2+ on dipstick or routine urinalysis.
    • Absolute neutrophil count 1.5 × 10^9/Liter (L), platelets 100 × 10^9/L, and hemoglobin 9 g/deciliter (dL) (5.58 millimoles/Liter).
    • International normalized ratio 1.5 × ULN or prothrombin time 5 seconds above ULN.
    • Partial thromboplastin time 5 seconds above ULN.
  • The participant has an estimated life expectancy of 12 weeks in the judgment of the investigator.
  • The participant, if female and of child-bearing potential, must have a negative serum or urine pregnancy test within 7 days prior to randomization.

Exclusion Criteria:

  • The participant has squamous cell or undifferentiated gastric cancer.
  • The participant is receiving chronic therapy with any of the following within 7 days prior to randomization:

    • Nonsteroidal anti-inflammatory agents (NSAIDs; such as indomethacin, ibuprofen, naproxen, or similar agents), or
    • Other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or anagrelide). Aspirin use at doses up to 325 milligrams (mg)/day is permitted.
  • The participant received radiotherapy within 14 days prior to randomization.
  • The participant received >1 line of prior therapy for the treatment of locally advanced and unresectable or metastatic gastric or GEJ (Siewert Types I-III) adenocarcinoma.
  • The participant received previous treatment with agents targeting the vascular endothelial growth factor (VEGF)/VEGF receptor 2 signaling pathway.
  • The participant has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
  • The participant experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
  • The participant has symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
  • The participant has uncontrolled hypertension, as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, prior to initiating study treatment, despite antihypertensive intervention.
  • The participant underwent major surgery within 28 days prior to randomization or central venous access device placement within 7 days prior to randomization.
  • The participant has a history of gastrointestinal perforation or fistula within 6 months prior to randomization.
  • The participant has any condition (for example, psychological, geographical, or medical) that does not permit compliance with the study and follow-up procedures or suggests that the participant is, in the investigator's opinion, not an appropriate candidate for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443883


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02443883    
Other Study ID Numbers: 15608
I4T-MC-JVDB ( Other Identifier: Eli Lilly and Company )
2014-003791-23 ( EudraCT Number )
First Posted: May 14, 2015    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: June 29, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and european union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Keywords provided by Eli Lilly and Company:
stomach cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Ramucirumab
Antineoplastic Agents