ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Active, not recruiting
First Posted : May 14, 2015
Results First Posted : March 13, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety and feasibility of administering higher doses of ramucirumab in participants with gastric cancer.

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

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
Study Start Date : June 2015
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ramucirumab

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

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

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

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




Primary Outcome Measures :
  1. Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Week 4, 6, 10 and 12: predose ]
    The Cmin is the minimum observed serum concentration of ramucirumab.


Secondary Outcome Measures :
  1. 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.

  2. Rate of Progression Free Survival at 6 Weeks [ Time Frame: Baseline until Disease Progression or Death Due to Any Cause Up to 6 Weeks ]
    PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause.Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions,with reference being the smallest sum on study and plus absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions. If participant does not have complete baseline disease assessment,then PFS time will be censored at date of first dose,regardless of whether or not objectively determined disease progression or death has been observed for participant.If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis,PFS time will be censored at last adequate tumor assessment date.PFS survival rate at 6 weeks was estimated using the Kaplan-Meier method which takes into consideration who was censored prior to 6 weeks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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).
  • 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


  Show 45 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02443883     History of Changes
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: August 15, 2018
Last Verified: July 2018

Keywords provided by Eli Lilly and Company:
stomach cancer

Additional relevant MeSH terms:
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
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs