NCT02065765|Unknown

International Expanded Access Program to Provide Ramucirumab for the Treatment of Metastatic Gastric Cancer

An International Single-Arm Protocol to Provide Expanded Access to Ramucirumab for the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression After Prior Fluoropyrimidine and/or Platinum-Containing Chemotherapy

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

14945I4T-MC-JVCP

Study Type

expanded_access

Target

N/A

Locations

5 countries

Sites

Timeline

RegisteredFeb 2014

Brief Summary

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the compassionate use program.

Trial Health

Monitor

Trial Health Score

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

Geographic Reach

5 countries

44 active sites

Status

unknown

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

February 17, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed

Last Updated

January 9, 2025

Status Verified

January 1, 2025

First QC Date

February 17, 2014

Last Update Submit

January 7, 2025

Conditions

Metastatic Gastric Cancer Metastatic Adenocarcinoma of the Gastroesophageal Junction

Interventions

RamucirumabBIOLOGICAL

Administered intravenously (IV)

Also known as: LY3009806, IMC-1121B

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The participant has histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma. (Participants with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ)
The participant has metastatic disease or locally recurrent, unresectable disease
The participant has measureable or evaluable disease as determined by standard computed tomography (CT) or magnetic resonance imaging (MRI) imaging. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
The participant has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy for metastatic disease, or during treatment, or within 6 months after the last dose of adjuvant therapy
o Acceptable prior chemotherapy regimens for this protocol are combination chemotherapy regimens that include platinum and/or fluoropyrimidine components. Regimens including a third agent, such as an anthracycline or a taxane, are acceptable provided a fluoropyrimidine and/or a platinum were used.
The participant has resolution to Grade ≤1 (or to Grade ≤2 in the case of neuropathy) by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia)
The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
The participant has adequate hepatic function
The participant does not have:
cirrhosis at a level of Child-Pugh B (or worse) or
cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
The participant has adequate renal function as defined by a serum creatinine ≤1.5 times the upper limit of normal (ULN), or creatinine clearance (measured via 24-hour urine collection) ≥40 milliliter per minute (mL/minute)
The participant's urinary protein is ≤1+ on dipstick or routine urinalysis (UA)
The participant has adequate hematologic function
The participant must have adequate coagulation function
+3 more criteria

You may not qualify if:

The participant has documented and/or symptomatic brain or leptomeningeal metastases
The participant has experienced any Grade 3 to 4 gastrointestinal (GI) bleeding within 3 months prior to enrollment
The participant has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment
The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the treating physician
The participant has ongoing or active psychiatric illness or social situation that would limit compliance with treatment
The participant has uncontrolled or poorly controlled hypertension \[\>160 milliliter of mercury (mmHg) systolic or \>100 mmHg diastolic for \>4 weeks\] despite standard medical management
The participant has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment
The participant has received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to enrollment
The participant has received any investigational therapy within 30 days prior to enrollment
The participant has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
The participant has received prior therapy with an agent that directly inhibits vascular endothelial growth factor (VEGF) (including bevacizumab), or vascular endothelial growth factor receptor-2 (VEGFR-2) activity, or any antiangiogenic agent
The participant is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs; including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted
The participant has elective or planned major surgery to be performed during the course of the clinical trial
The participant has a known allergy to any of the treatment components
The participant is pregnant or breastfeeding
+5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (44)

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.

Graz, 8036, Austria

Location

Innsbruck, 6020, Austria

Location

Linz, 4020, Austria

Location

Salzburg, 5020, Austria

Location

Steyr, 4400, Austria

Location

Vienna, 1130, Austria

Location

Zams, 6511, Austria

Location

Berlin, 13125, Germany

Location

Dresden, 01307, Germany

Location

Essen, 45122, Germany

Location

Friedrichshafen, 88045, Germany

Location

Hamburg, 20246, Germany

Location

Heidelberg, 69115, Germany

Location

Kaiserslautern, 67655, Germany

Location

Mönchengladbach, 41063, Germany

Location

Mönchengladbach, 41238, Germany

Location

Ulm, 02763, Germany

Location

Wolfsburg, 38440, Germany

Location

Athens, 11526, Greece

Location

Athens, 15562, Greece

Location

Heraklion, 71110, Greece

Location

Marousi, 15123, Greece

Location

Neo Faliro, 18547, Greece

Location

Thessaloniki, 57001, Greece

Location

Amsterdam, 1105 AZ, Netherlands

Location

Busan, 48108, South Korea

Location

Cheong Ju-City, 361-711, South Korea

Location

Chuncheon, 14068, South Korea

Location

Daejeon, 35015, South Korea

Location

Deagu, 41404, South Korea

Location

Gangnam-gu, 06351, South Korea

Location

Gangwon Do, 24289, South Korea

Location

Guri-si, 11923, South Korea

Location

Gyeonggi-do, 463-070, South Korea

Location

Incheon, 405-760, South Korea

Location

Jeonbuk, 54907, South Korea

Location

Jinju, 52727, South Korea

Location

Jongno-gu, 03080, South Korea

Location

Namdong-gu, 405-760, South Korea

Location

Seongnam-si, 463-707, South Korea

Location

Seowon-gu, 28644, South Korea

Location

Suwon, 16247, South Korea

Location

Taegu, 41931, South Korea

Location

Ulsan, 44033, South Korea

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

Study Design

Study Type: expanded access
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 19, 2014

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

DE(11)NL(1)KR(19)GR(6)AU(7)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Conditions

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (44)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations