- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04888663
Study of Ramucirumab, Trastuzumab and Paclitaxel in Patients With HER2-positive Recurrent/Metastatic Gastric Cancer (HER-RAM Study)
May 18, 2021 updated by: Yonsei University
An Open-label, Multicenter Phase Ib/II Study of Ramucirumab in Combination With Trastuzumab and Weekly Paclitaxel in Patients With HER2-positive Recurrent/Metastatic Gastric Cancer
Human epidermal growth factor receptor 2 (HER2) is overexpressed or amplified in 10-20% of gastric or gastroesophageal junction cancer.
Trastuzumab combined with fluorouracil and platinum has been established as first-line treatment for patients with HER2-positive gastric cancer.
The role of trastuzumab in second-line treatment for HER2-positive gastric cancer has not yet been addressed.
Here, we evaluated the safety and efficacy of adding trastuzumab to ramucirumab and paclitaxel combination as a second-line treatment in HER2-positive gastric cancer progressed after trastuzumab-containing chemotherapy.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seodaemun-gu
-
Seoul, Seodaemun-gu, Korea, Republic of, 03722
- Yonsei University Health System, Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically proven metastatic or locally advanced HER2-positive gastric cancer
- Documented disease progression after receiving prior line of trastuzumab-containing chemotherapy for gastric cancer
- Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
- Eligible male and female subjects aged ≥19 years.
- Has measurable disease as determined by RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Has baseline left ventricular ejection fraction (LVEF) ≥ 55%.
- Adequate organ function as demonstrated by laboratory test results within 14 days prior to first dose of study treatment.
- Have urinary protein that is <2 on dipstick or routine urinalysis.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to first dose of study treatment.
- Female subjects of childbearing potential and male subjects should be willing to use methods of birth control for the course of the study and up to 120 days after the last dose of study treatment.
Exclusion Criteria:
- Received prior anticancer treatment with targeted agents, chemotherapy, or radiotherapy within 14 days, with monoclonal antibodies within 28 days, has previously received treatment with ramucirumab, or has participated in another clinical trial within 14 days prior to start of study treatment.
- Has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to treatment.
- Has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 3 months prior to treatment.
- Has history of severe thromboembolism, including deep vein thrombosis and pulmonary embolism within 6 months prior to treatment.
- Has an active or ongoing infection, symptomatic congestive heart failure, uncontrolled angina pectoris, symptomatic or poorly controlled arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.
- Has ongoing or active psychiatric illness or social situation that would limit compliance with study requirements.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has evidence of active, non-infectious pneumonitis.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has known active hepatitis B or hepatitis C.
- Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 4 weeks prior to enrollment.
- Has history of GI perforation and/or fistula within 6 months prior to treatment.
- Is pregnant or breastfeeding, or possibly pregnant.
- Has history of Child-Pugh Class B or more of liver cirrhosis or hepatic encephalopathy, or cirrhosis with clinically meaningful ascites.
- Is undergoing long-term antiplatelet therapy within 7 days prior to treatment.
- Has known history of hypersensitivity to one or more of the study treatments or their substances, or known severe hypersensitivity to monoclonal antibodies.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study treatment
(Phase Ib part) Trastuzumab 4 mg/kg (loading dose) followed by 2 mg/kg IV, ramucirumab 8 mg/kg IV, and paclitaxel 80 or 70 mg/m2 IV (according to dose level) (Phase II part) Trastuzumab 4 mg/kg (loading dose) followed by 2 mg/kg IV, ramucirumab 8 mg/kg IV, and paclitaxel at RP2D (80 or 70 mg/m2 IV)
|
For both Phase Ib and II: Trastuzumab 4 mg/kg (loading dose) followed by 2 mg/kg on Days 1, 8, 15 and 22, and ramucirumab 8 mg/kg on Days 1 and 15, as well as paclitaxel will be administered intravenously in a 4-week cycle (every 28 days) For Phase Ib, Paclitaxel 80 or 70 mg/m2 (according to dose level) will be administered on Days 1, 8, 15 For Phase II, paclitaxel at RP2D (80 or 70 mg/m2) will be administered on Days 1, 8, 15 of each cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phase 1b: Maximum tolerated dose of trastuzumab, ramucirumab, and paclitaxel combination treatment in patients with HER2-positive gastric cancer
Time Frame: Phase 1b: During the first 4 weeks of treatment
|
Phase 1b: During the first 4 weeks of treatment
|
Phase 2: Progression-free survival in patients with HER2-positive gastric cancer receiving trastuzumab, ramucirumab, and paclitaxel combination treatment
Time Frame: Phase 2: At 24 weeks after start of treatment
|
Phase 2: At 24 weeks after start of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: through study completion, an average of 2 years
|
through study completion, an average of 2 years
|
Objective response rate according to RECIST 1.1
Time Frame: through study completion, an average of 2 years
|
through study completion, an average of 2 years
|
Disease control rate according to RECIST 1.1
Time Frame: through study completion, an average of 2 years
|
through study completion, an average of 2 years
|
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE v4.02
Time Frame: Throughout the overall study period as well as up to 3 months after the last dose study treatment for each subject
|
Throughout the overall study period as well as up to 3 months after the last dose study treatment for each subject
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2018
Primary Completion (Anticipated)
September 2, 2021
Study Completion (Anticipated)
September 2, 2021
Study Registration Dates
First Submitted
May 9, 2021
First Submitted That Met QC Criteria
May 14, 2021
First Posted (Actual)
May 17, 2021
Study Record Updates
Last Update Posted (Actual)
May 21, 2021
Last Update Submitted That Met QC Criteria
May 18, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Recurrence
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Paclitaxel
- Trastuzumab
- Ramucirumab
Other Study ID Numbers
- 4-2017-0275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent/Metastatic Gastric Cancer
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Esophageal Carcinoma | Recurrent Gastric Carcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Metastatic Esophageal Carcinoma | Metastatic Gastric Carcinoma | Stage IV Esophageal Cancer AJCC v7 | Stage IV Gastric Cancer... and other conditionsUnited States
-
Hanmi Pharmaceutical Company LimitedUnknownRecurrent Gastric Cancer | Advanced Metastatic Gastric CancerKorea, Republic of
-
Yonsei UniversityNot yet recruitingRecurrent/Metastatic Gastric CancerKorea, Republic of
-
Yonsei UniversityCompletedRecurrent or Metastatic Gastric CancerKorea, Republic of
-
National Taiwan University HospitalCompletedLocally Advanced and Recurrent/Metastatic Gastric Cancer
-
Asan Medical CenterHoffmann-La RocheCompletedMetastatic or Recurrent Gastric Adenocarcinoma | Her-2 Positive Gastric CancerKorea, Republic of
-
Jiangsu HengRui Medicine Co., Ltd.The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUnknownRecurrent and Metastatic Gastric CancerChina
-
Memorial Sloan Kettering Cancer CenterRecruitingMetastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastric Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Metastatic Gastric Cancer | Unresectable Esophageal Cancer | Metastatic Esophageal Carcinoma | Metastatic Gastric... and other conditionsUnited States
-
City of Hope Medical CenterRecruitingGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditionsUnited States, Japan
-
Royal Marsden NHS Foundation TrustRecruitingMetastatic Gastric Cancer | Metastatic Esophageal CancerUnited Kingdom
Clinical Trials on Trastuzumab + Ramucirumab + Paclitaxel
-
Seagen Inc.Active, not recruitingGastric Adenocarcinoma | Esophageal Adenocarcinoma | Gastroesophageal Junction AdenocarcinomaUnited States, Korea, Republic of, United Kingdom, Taiwan, Canada, Australia
-
Tianjin Medical University Cancer Institute and...RecruitingGastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)China
-
Liza Villaruz, MDCompleted
-
Eli Lilly and CompanyCompletedMalignant Solid TumorUnited States
-
Novartis PharmaceuticalsCompletedMetastatic or Locally Advanced Solid TumorsNetherlands, Spain, Germany, Switzerland, Belgium
-
Korean South West Oncology GroupWithdrawnGastric CancerKorea, Republic of
-
ALX Oncology Inc.Eli Lilly and CompanyRecruitingGastric Cancer | Gastric Adenocarcinoma | Gastroesophageal Junction AdenocarcinomaUnited States, Spain, France, Korea, Republic of, Taiwan, United Kingdom, Japan, Singapore, Belgium, Czechia, Italy
-
Yang Jianjun, PhDRecruiting
-
SCRI Development Innovations, LLCCelgeneCompletedGastroesophageal CancerUnited States
-
Guangdong Provincial People's HospitalUnknown