NCT02443883

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2015

Typical duration for phase_2

Geographic Reach
12 countries

45 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 13, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
Last Updated

June 29, 2020

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

May 12, 2015

Results QC Date

October 28, 2017

Last Update Submit

June 26, 2020

Conditions

Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

Keywords

stomach cancer

Outcome Measures

Primary Outcomes (1)

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

    The Cmin is the minimum observed serum concentration of ramucirumab.

    Day 29, 43, 71 and 85: predose

Secondary Outcomes (2)

  • Immunogenicity: Number of Participants With Anti-Ramucirumab Antibodies

    Predose Cycle 1 Through Short Term Follow Up (Up to 5 Months)

  • Rate of Progression Free Survival (PFS) at the First 6-Week Tumor Assessment

    Baseline until the first 6-week tumor assessment

Study Arms (4)

Ramucirumab Regimen 1

EXPERIMENTAL

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

Ramucirumab Regimen 2

EXPERIMENTAL

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

Ramucirumab Regimen 3

EXPERIMENTAL

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

Ramucirumab Regimen 4

EXPERIMENTAL

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

Interventions

RamucirumabDRUG

Administered IV

Also known as: LY3009806, IMC-1121B
Ramucirumab Regimen 1Ramucirumab Regimen 2Ramucirumab Regimen 3Ramucirumab Regimen 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

USC Norris Cancer Hospital

Los Angeles, California, 90033, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Oklahoma Cancer Specialists & Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

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.

Buenos Aires, 1025, Argentina

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.

Rosario, 2000, Argentina

Location

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San Miguel de Tucumán, T4000IAK, Argentina

Location

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Viedma, 8500, Argentina

Location

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Adelaide, 5000, Australia

Location

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Kingswood, 2747, Australia

Location

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Melbourne, 3144, Australia

Location

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Nedlands, 6009, Australia

Location

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Brest, 29609, France

Location

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Créteil, 94010, France

Location

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Dijon, 21079, France

Location

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Lyon, 69437, France

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.

Paris, 75012, France

Location

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Paris, 75013, France

Location

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Budapest, 1125, Hungary

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.

Szolnok, 5000, Hungary

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.

Auckland, 1023, New Zealand

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.

Christchurch, 8011, New Zealand

Location

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Gdansk, 80-219, Poland

Location

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Lodz, 90-242, Poland

Location

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Poznan, 61-485, Poland

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.

Warsaw, 04-125, Poland

Location

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Baia Mare, 430031, Romania

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

Cluj-Napoca, 400058, Romania

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.

Craiova, 200347, Romania

Location

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, 163045, Russia

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.

Kursk, 305035, Russia

Location

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Moscow, 115478, Russia

Location

Leningrad regional clinical hospital

Saint Petersburg, 194291, Russia

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

Bratislava, 833 10, Slovakia

Location

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Košice, 041-90, Slovakia

Location

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Edirne, 22030, Turkey (Türkiye)

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.

Fatih, 34093, Turkey (Türkiye)

Location

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Medreseboğazı, 1250, Turkey (Türkiye)

Location

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Pendik, 34668, Turkey (Türkiye)

Location

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Cardiff, CF14 2TL, United Kingdom

Location

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Exeter, EX2 5DW, United Kingdom

Location

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Leeds, LS9 7TF, United Kingdom

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.

Manchester, M20 4BX, United Kingdom

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.

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Ramucirumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
clinicaltrials.gov@lilly.com
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 14, 2015

Study Start

July 7, 2015

Primary Completion

November 18, 2016

Study Completion

June 5, 2019

Last Updated

June 29, 2020

Results First Posted

March 13, 2018

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations

NZ(2)PL(4)AR(4)AU(4)RO(3)TU(4)FR(6)US(5)HU(2)RU(4)SL(2)GB(5)