Ramucirumab Plus Irinotecan for Previously Treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03141034|
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma Gastro-esophageal Junction Adenocarcinoma||Drug: Irinotecan Drug: Ramucirumab Genetic: Blood for angiome profiling Genetic: Blood for cfDNA||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ramucirumab Plus Irinotecan in Patients With Previously Treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Irinotecan plus ramucirumab
-Patients will receive ramucirumab intravenously on an outpatient basis at a dose of 8 mg/kg over the course of 60 minutes on Day 1 of each 14-day cycle. They will then receive irinotecan intravenously at a dose of 180 mg/m2 over the course of 90 minutes on Day 1 of each 14-day cycle.
-Irinotecan is commercially available and will be billed to insurance.
-Ramucirumab will be provided free of charge by Eli Lilly and Company.
Other Name: Cyramza®
Genetic: Blood for angiome profiling
-Before treatment on cycle 1 day 1, cycle 5 day 1, cycle 9 day 1, and end of treatment
Genetic: Blood for cfDNA
-Before treatment on cycle 1 day 1, cycle 3 day 1, cycle 5 day 1, cycle 7 day 1, cycle 9 day 1, and end of treatment
- Progression-free survival (PFS) [ Time Frame: Up to 18 months from completion of treatment (estimated median treatment and follow-up of 10 months) ]-PFS will be measured from date of study entry to first radiographic progression or death due to any cause. Radiographic progressive disease (PD) will be defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1). For those who are alive and do not experience progression, the investigators will censor them at the time of loss to follow-up (very few) or at 12 months from the study entry, whichever comes first.
- Overall survival (OS) [ Time Frame: Up to 18 months from completion of treatment (estimated median treatment and follow-up of 10 months) ]-OS time will be measured from date of study entry to date of death from any cause. For those who are alive, the investigators will censor them at the time of loss to follow-up (very few) or at 12 months from the study entry, whichever comes first.
- Time to progressive disease (TTP) [ Time Frame: Up to 18 months from completion of treatment (estimated median treatment and follow-up of 10 months) ]-TTP is defined as the time from study entry until date of radiographic PD using RECIST v1.1 criteria. For those who are alive and do not experience progression, the investigators will censor them at the time of loss to follow-up (very few) or at 12 months from the study entry, whichever comes first. For those who are dead before progression, the investigators will consider death as the competing risk. If the number of death are very small, the investigators will censor them at time of death.
- Best overall response (BOR) [ Time Frame: Up to end of treatment (estimated to be 6 months) ]-BOR is defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 criteria. CR is defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR is defined as having a ≥30% decrease in sum of longest diameter (LD) of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.
- Objective response rate (ORR) [ Time Frame: Up to end of treatment (estimated to be 6 months) ]-ORR defined as confirmed complete response + confirmed partial response
- Clinical benefit rate (CBR) [ Time Frame: Up to end of treatment (estimated to be 6 months) ]-CBR defined as percentage of combined participants who have achieved confirmed complete response, confirmed partial response, and stable disease
- Toxicity and tolerability of regimen as measured by the count of the worst grade of adverse event experienced by each participant [ Time Frame: Up to 30 days following completion of treatment (estimated to be 7 months) ]-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
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): NCT03141034
|Contact: Haeseong Park, M.D., MPH||(314) firstname.lastname@example.org|
|United States, Florida|
|University of Miami - Sylvester Comprehensive Cancer Center||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Albert C Lockhart, M.D. 305-243-0116 email@example.com|
|Principal Investigator: Albert C Lockhart, M.D.|
|Sub-Investigator: Bach Ardalan, M.D.|
|Sub-Investigator: Peter J Hosein, M.D.|
|Sub-Investigator: Agustin Pimentel, M.D.|
|H. Lee Moffitt Cancer Center and Research Institute, Inc.||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Rutika Mehta, M.D. 813-745-1277 firstname.lastname@example.org|
|Principal Investigator: Rutika Mehta, M.D.|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Haeseong Park, M.D, MPH 314-747-7401 email@example.com|
|Principal Investigator: Haeseong Park, M.D., MPH|
|Sub-Investigator: Manik Amin, M.D,|
|Sub-Investigator: Eric Knoche, M.D.|
|Sub-Investigator: Kian Lim, M.D.|
|Sub-Investigator: Peter Oppelt, M.D.|
|Sub-Investigator: Katrina Pederson, M.D.|
|Sub-Investigator: Joel Picus, M.D.|
|Sub-Investigator: Caron Rigden, M.D.|
|Sub-Investigator: Rama Suresh, M.D.|
|Sub-Investigator: Benjamin Tan, M.D.|
|Sub-Investigator: Andrea Wang-Gillam, M.D.|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Aravind Sanjeevaiah, M.D. 214-645-8300|
|Principal Investigator: Aravind Sanjeevaiah, M.D.|
|Sub-Investigator: Muhammad Beg, M.D.|
|Sub-Investigator: Leticia Khosama, N.P.|
|Sub-Investigator: Udit Verma, M.D.|
|Principal Investigator:||Haeseong Park, M.D., MPH||Washington University School of Medicine|