NCT01983878

Brief Summary

The purpose of this study is to evaluate progression-free survival in participants with gastric or gastroesophageal junction cancer who have had disease progression following first-line therapy who undergo treatment with ramucirumab.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_2 gastric-cancer

Geographic Reach
1 country

11 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

November 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
21 days until next milestone

Results Posted

Study results publicly available

February 22, 2016

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

November 7, 2013

Results QC Date

January 25, 2016

Last Update Submit

September 10, 2019

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks)

    The 12-week PFS rate is the probability of participants who survived during the first 12 weeks in the study without disease progression. It was estimated using the Kaplan-Meier method for the main analysis of the 12-week PFS rate.

    12 Weeks

Secondary Outcomes (7)

  • Progression-Free Survival (PFS)

    Baseline to Measured PD or Death from Any Cause (Up to 30.3 weeks)

  • Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

    Baseline to Measured PD or Death from Any Cause (Up to 38.0 Weeks)

  • Percentage of Participants Achieving Stable Disease (SD) or a Confirmed CR or PR [Disease Control Rate (DCR)]

    Baseline to Measured PD or Death from Any Cause (Up to 12 Months)

  • Overall Survival (OS)

    Baseline to Death from Any Cause (Up to 13 Months)

  • Number of Participants With Anti-Ramucirumab Antibodies

    Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion, Follow Up

  • +2 more secondary outcomes

Study Arms (1)

Ramucirumab

EXPERIMENTAL

Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment will continue until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance or withdrawal of consent.

Drug: Ramucirumab

Interventions

RamucirumabDRUG

Administered IV

Also known as: LY3009806, IMC-1121B
Ramucirumab

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma
  • Metastatic disease or locally recurrent, unresectable disease
  • Measurable disease and/or evaluable disease
  • Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy
  • Life expectancy of at least 3 months
  • Resolution to Grade less than or equal to 1 by the National Cancer Institute Common Terminology Criteria for Adverse , Version 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
  • Eastern Cooperative Oncology Group performance status score of 0-1
  • Has adequate organ function
  • Must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods), if sexually active
  • Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment

You may not qualify if:

  • Documented and/or symptomatic brain or leptomeningeal metastases
  • Bone metastases
  • Experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment
  • Experienced any arterial thromboembolic event within 6 months prior to enrollment
  • Ongoing or active significant infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thromboembolic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator
  • Ongoing or active psychiatric illness or social situation that would limit compliance with study requirements
  • Blood pressure in abnormal range despite standard medical management
  • Has a serious or nonhealing wound, ulcer, or bone fracture
  • Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer
  • Received any investigational therapy within 30 days prior to enrollment
  • Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
  • Received prior therapy with an agent that directly inhibits vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor 2 (VEGFR-2) activity (including bevacizumab), or any anti-angiogenic agent
  • Receiving chronic therapy with nonsteroidal anti-inflammatory drugs or receiving other antiplatelet agents. Aspirin use at doses up to 325 milligrams per day is permitted
  • Has elective or planned major surgery to be performed during the course of the clinical study
  • Has a known allergy to any of the treatment components
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

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, 260-8717, 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.

Hokkaido, 060-8648, 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.

Hyōgo, 650-0047, 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.

Kanagawa, 224-8503, 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, 558-8558, 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, 569-8686, 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.

Saitama, 362-0806, 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.

Shizuoka, 411-8777, 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.

Tokyo, 181-8611, Japan

Location

Related Publications (1)

  • Yamaguchi K, Fujitani K, Nagashima F, Omuro Y, Machida N, Nishina T, Koue T, Tsujimoto M, Maeda K, Satoh T. Ramucirumab for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma following disease progression on first-line platinum- or fluoropyrimidine-containing combination therapy in Japanese patients: a phase 2, open-label study. Gastric Cancer. 2018 Nov;21(6):1041-1049. doi: 10.1007/s10120-018-0811-4. Epub 2018 Mar 5.

    PMID: 29508095DERIVED

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
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
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 14, 2013

Study Start

December 1, 2013

Primary Completion

January 1, 2015

Study Completion

February 1, 2016

Last Updated

September 30, 2019

Results First Posted

February 22, 2016

Record last verified: 2019-09

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 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

JP(11)