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A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer

Primary Purpose

Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Ramucirumab

Paclitaxel

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring stomach cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The participant has a diagnosis of gastric or GEJ adenocarcinoma.
The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.
The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors 1.1.
The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1.
The participant has adequate organ function:
- Total bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the liver has tumor involvement, AST and ALT <5 × ULN.
- Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 milliliters/minute.
- Urinary protein is <2+.
- Absolute neutrophil count ≥1.5 × 10^9/liter (L), platelets ≥100 × 10^9/L, and hemoglobin ≥9 grams/deciliter (5.58 millimoles/L).
- International normalized ratio ≤1.5 × ULN and partial thromboplastin time ≤5 seconds above ULN.
The participant has an estimated life expectancy of minimum 12 weeks.
The participant has resolution to Grade 1 or less by Common Terminology Criteria for Adverse Events Version 4.0, of all clinically significant toxic effects of previous therapy.
The participant, if male, is sterile or agrees to use a reliable method of birth control.
The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control.
The participant, if female and of child-bearing potential, must have a negative pregnancy test.

Exclusion Criteria:

The participant is receiving therapy with any of the following:
- Nonsteroidal anti-inflammatory agents.
- Other anti-platelet agents; 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 previous chemotherapy with a cumulative dose of >900 mg per meter squared (mg/m^2) of epirubicin or >400 mg/m^2 of doxorubicin.
The participant has documented brain metastases or leptomeningeal disease.
The participant has a significant bleeding disorder or vasculitis.
The participant experienced any arterial thromboembolic event within 6 months.
The participant has symptomatic congestive heart failure or symptomatic cardiac arrhythmia.
The participant has uncontrolled hypertension, despite antihypertensive intervention.
The participant underwent major surgery within 28 days.
The participant has a history of gastrointestinal perforation or fistula within 6 months.
The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months.
The participant has bowel obstruction or history of chronic diarrhea that is considered clinically significant.
The participant has either of the following:
- Child-pugh B or C cirrhosis.
The participant has a serious illness or medical condition including:
- Human immunodeficiency virus infection.
The participant has a concurrent active malignancy other than the following:
- Nonmelanomatous skin cancer.
- In situ carcinoma of the cervix or other noninvasive carcinoma or in situ neoplasm.
The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone fracture.
The participant experienced any Grade 3 or 4 venous thromboembolic event that is not adequately treated.

Sites / Locations

City of Hope National Medical Center
University of Kansas Medical Center
Dana Farber Cancer Institute
Montefiore Medical Center
Weill Cornell Medical College
Scott & White Memorial Hospital & Clinic
Vista Oncology Inc. PS
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.
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.
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.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

12mg/kg Ramucirumab + 80 mg/m² Paclitaxel

8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel

Arm Description

12 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 milligram per square meter (mg/m²) paclitaxel administered IV on day 1, day 8 and day 15.

8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ

PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment (AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.

Secondary Outcome Measures

Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ

PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment(AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination with Paclitaxel

Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])

ORR was defined as the percentage of participants who achieved a PR or CR per RECIST v.1.1.CR is the disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to<10mm.Tumor marker results must have normalized.PR is at least a 30% decrease in the sum of diameter of target lesions,taking as reference the baseline sum diameters.ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.

Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)]

DCR is defined as the percentage of participants who achieved CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm.Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression. Non-Target PD is unequivocal progression of existing nontarget lesions. DCR=CR+PR+SD/total number of participants*100.

Number of Participants With Anti-Ramucirumab Antibodies

Participants who had anti-ramucirumab antibodies at postbaseline.

Full Information

NCT ID

NCT02514551

First Posted

July 31, 2015

Last Updated

June 10, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02514551

Brief Title

A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer

Official Title

Randomized Phase 2 Trial Evaluating Alternative Ramucirumab Doses in Combination With Paclitaxel in Second-Line Metastatic or Locally Advanced, Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 1, 2020

Overall Recruitment Status

Completed

Study Start Date

October 12, 2015 (Actual)

Primary Completion Date

October 27, 2017 (Actual)

Study Completion Date

December 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy of an alternative dose of ramucirumab in combination with paclitaxel in participants with second-line metastatic or locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Keywords

stomach cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

245 (Actual)

8. Arms, Groups, and Interventions

Arm Title

12mg/kg Ramucirumab + 80 mg/m² Paclitaxel

Arm Type

Experimental

Arm Description

Arm Title

8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel

Arm Type

Active Comparator

Arm Description

8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.

Intervention Type

Drug

Intervention Name(s)

Ramucirumab

Other Intervention Name(s)

LY3009806, IMC-1121B, Cyramza

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ

Description

Time Frame

Randomization to Objective Progressive Disease or Death (Up To 21 Months)

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ

Description

PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment(AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.

Time Frame

Randomization to Objective Progressive Disease or Death (Up To 21 Months)

Title

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel

Description

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination with Paclitaxel

Time Frame

Cycle(C) 1 Day(D) 1: Prior to Infusion(PTI),1 to 1.5 hours(hrs) after end of Infusion(EOI); C1 D15: 3 days PTI; C2 D1: 3 days PTI; C2 D15: 3 days PTI,1 to 1.5 hrs after EOI; C3 D1 and 15: 3 days PTI; C4 D1: 3 days PTI and 1 to 1.5 hrs after EOI

Title

Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])

Description

Time Frame

Baseline to Objective Progressive Disease (Up To 21 Months)

Title

Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)]

Description

Time Frame

Baseline to Objective Progressive Disease (Up To 21 Months)

Title

Number of Participants With Anti-Ramucirumab Antibodies

Description

Participants who had anti-ramucirumab antibodies at postbaseline.

Time Frame

Cycle 1 Predose through Follow-up (Up To 24 Months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The participant has a diagnosis of gastric or GEJ adenocarcinoma. The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy. The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent. The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors 1.1. The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1. The participant has adequate organ function: Total bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the liver has tumor involvement, AST and ALT <5 × ULN. Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 milliliters/minute. Urinary protein is <2+. Absolute neutrophil count ≥1.5 × 10^9/liter (L), platelets ≥100 × 10^9/L, and hemoglobin ≥9 grams/deciliter (5.58 millimoles/L). International normalized ratio ≤1.5 × ULN and partial thromboplastin time ≤5 seconds above ULN. The participant has an estimated life expectancy of minimum 12 weeks. The participant has resolution to Grade 1 or less by Common Terminology Criteria for Adverse Events Version 4.0, of all clinically significant toxic effects of previous therapy. The participant, if male, is sterile or agrees to use a reliable method of birth control. The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control. The participant, if female and of child-bearing potential, must have a negative pregnancy test. Exclusion Criteria: The participant is receiving therapy with any of the following: Nonsteroidal anti-inflammatory agents. Other anti-platelet agents; 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 previous chemotherapy with a cumulative dose of >900 mg per meter squared (mg/m^2) of epirubicin or >400 mg/m^2 of doxorubicin. The participant has documented brain metastases or leptomeningeal disease. The participant has a significant bleeding disorder or vasculitis. The participant experienced any arterial thromboembolic event within 6 months. The participant has symptomatic congestive heart failure or symptomatic cardiac arrhythmia. The participant has uncontrolled hypertension, despite antihypertensive intervention. The participant underwent major surgery within 28 days. The participant has a history of gastrointestinal perforation or fistula within 6 months. The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months. The participant has bowel obstruction or history of chronic diarrhea that is considered clinically significant. The participant has either of the following: Child-pugh B or C cirrhosis. The participant has a serious illness or medical condition including: Human immunodeficiency virus infection. The participant has a concurrent active malignancy other than the following: Nonmelanomatous skin cancer. In situ carcinoma of the cervix or other noninvasive carcinoma or in situ neoplasm. The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone fracture. The participant experienced any Grade 3 or 4 venous thromboembolic event that is not adequately treated.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

City of Hope National Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010-0269

Country

United States

Facility Name

University of Kansas Medical Center

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Scott & White Memorial Hospital & Clinic

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

Vista Oncology Inc. PS

City

Olympia

State/Province

Washington

ZIP/Postal Code

98502

Country

United States

Facility Name

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.

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Calgary

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

City

Oshawa

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

City

Novy Jicin

ZIP/Postal Code

741 01

Country

Czechia

Facility Name

City

Praha

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

City

Praha

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

City

Frankfurt am Main

ZIP/Postal Code

60488

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

City

Ravensburg

ZIP/Postal Code

88212

Country

Germany

Facility Name

City

Athens

ZIP/Postal Code

18537

Country

Greece

Facility Name

City

Haidari

ZIP/Postal Code

12462

Country

Greece

Facility Name

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

City

N. Efkarpia

ZIP/Postal Code

56403

Country

Greece

Facility Name

City

Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

City

Cagliari

ZIP/Postal Code

09042

Country

Italy

Facility Name

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

City

Faenza

ZIP/Postal Code

48018

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

Facility Name

City

San Giovanni Rotondo

ZIP/Postal Code

71013

Country

Italy

Facility Name

City

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

17007

Country

Spain

Facility Name

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

City

Goteborg

ZIP/Postal Code

413 56

Country

Sweden

Facility Name

City

Linkoping

ZIP/Postal Code

58185

Country

Sweden

Facility Name

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

City

Edirne

ZIP/Postal Code

22770

Country

Turkey

Facility Name

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

City

Malatya

ZIP/Postal Code

44280

Country

Turkey

Facility Name

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

City

Kyiv

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

City

Lutsk

ZIP/Postal Code

63000

Country

Ukraine

Facility Name

City

Sumy

ZIP/Postal Code

40005

Country

Ukraine

Facility Name

City

Vinnitsa

ZIP/Postal Code

21029

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Learn more about this trial

A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer

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