- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03766607
Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer
A Multi-center Phase II Study of Trastuzumab Biosimilar (SB3®) in Combination With Ramucirumab and Paclitaxel in HER2 Positive Metastatic Gastric Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately 15% of patients with advanced gastric cancer have HER2 overexpression and the combined use of trastuzumab and other cytotoxic chemotherapeutic agents, such as 5-FU and cisplatin, in these patients is associated with a significantly improved survival rate compared with cytotoxic chemotherapy alone. So, the combination of trastuzumab and chemotherapy is currently being used as a standard treatment in HER2 positive advanced gastric or gastroesophageal adenocarcinoma. However, after failing first line treatment with such regimen, second line treatment is determined regardless of HER2 status, and the most preferred treatment is ramucirumab and paclitaxel combination chemotherapy.
Recently, the use of trastuzumab in combination with other cytotoxic chemotherapeutic agents has been reported to be superior to the use of cytotoxic chemotherapy alone in the treatment of patients with HER2 positive metastatic breast cancer. On the basis of several guidelines, it is recommended to extend the use of trastuzumab after disease progression. In addition, in some retrospective studies of metastatic gastric cancer, it has been reported that treatment with trastuzumab in combination with second line chemotherapy followed by first line chemotherapy including trastuzumab is beneficial and it is worthwhile to be tested in the prospective study. Furthermore, data on the safety and efficacy of cross-administration of trastuzumab biosimilar have not been available yet.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Jeollabuk-do
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Jeonju, Jeollabuk-do, Korea, Republic of, 54907
- Chonbuk National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over 19 years old
- Histologically confirmed HER2 overexpressing gastric cancer (HER2 overexpression is defined as IHC 3+ or FISH +)
- Metastatic gastric cancer
- Progressive disease has been confirmed after first line treatment including trastuzumab (If the recurrence occurred within 6 months after the completion of postoperative adjuvant therapy, it can be considered as first line treatment.)
- At least one measurable or evaluable lesion according to RECIST ver 1.1
- ECOG performance status 0 or 1
- Appropriate major organ function as defined below, A. Absolute neutrophil count (ANC) ≥ 1,500/mm3 B. Platelet ≥ 100,000/mm3 C. Hemoglobin > 8.0 g/dL D. Total bilirubin ≤ 1.5 x ULN E. AST and ALT < 3 x ULN (if there is a live metastasis, AST and ALT ≤ 5 x ULN) F. Serum creatinine ≤ 1.5x ULN or CCr > 50 mL/min
- Life expectancy is more than 12 weeks
- Echocardiography at the time of enrollment showed an ejection fraction ≥ 50%
- Previous adverse events of chemotherapy or radiotherapy has been resolved to less than grade 1 toxicity (exception: Alopecia, stable peripheral neuropathy, and manageable electrolyte imbalance by replacement therapy are acceptable if they are resolved to less than grade 2)
- If the urine pregnancy test or serum beta-hCG result is negative in child bearing women
- If the subject have signed the informed consent form approved by the IRB
Exclusion Criteria:
- Symptomatic or unstable CNS metastasis (exception: appropriately treated brain metastasis without progression of more than 4 weeks after previous CT or MRI, and no steroid treatment for symptom relief is necessary)
- Active virus, bacteria, or fungal infection (exception: HBV DNA titer is in the normal range for chronic hepatitis B carriers)
- If previous chemotherapy or radiotherapy was applied within 3 weeks before the administration of study drug
- If the subject has received major surgery within 4 weeks and the recovery is not complete before the administration of study drug
- If there is a history of other malignancies within 3 years (exception: cervical intraepithelial cancer, well differentiated thyroid cancer, or skin cancer has been treated completely)
- QTc interval > 480 msec, long or short QT syndrome, or Burgada syndrome. In addition, known prolongation of QTc interval or Torsade de Pointes
- If there is a significant history of cardiovascular disease within 6 months, such as, myocardial infarction, unstable angina, significant cardiac arrhythmia, and uncontrolled hypertension (systolic BP > 180 mmHg, diastolic BP > 100 mmHg), congestive heart failure (NYHA class III-IV), pericardial effusion or pericardial tamponade, cardiomyopathy, cerebrovascular disease including transient ischemic stroke, and symptomatic pulmonary embolism.
- History of symptomatic interstitial pneumonia
- History of other psychiatric problems, abnormalities of laboratory test which have potential effects on administration of study drugs or participation on the study, or if the subject is inappropriate to be participated according to the investigator's decision (refusal to request and instruction, incooperative attitudes, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trastuzumab with Ramucirumab and Paclitaxel
Single arm study of trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) every 21 days + ramucirumab (8 mg/kg) on days 1 & 15 every 28 days + paclitaxel (80 mg/m2) on days 1, 8, and 15 every 28 days
|
Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days
Ramucirumab 8 mg/kg administered intravenously on days 1 and 15 every 28 days
Paclitaxel 80 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival, PFS
Time Frame: up to 12 months
|
as measured from the start of the treatment to the date of either documentation of disease progression or death
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up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate, ORR
Time Frame: up to 6 months
|
defined as the proportion of subjects who have a best overall response of complete response or partial response as assessed by RECIST 1.1
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up to 6 months
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Overall survival, OS
Time Frame: up to 12 months
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defined as the time from the date of randomization until the date of death from any cause
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up to 12 months
|
Adverse event
Time Frame: up to 12 months
|
as measured by NCI-CTCAE v5.0
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up to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eun-Kee Song, Korean Southwest Oncology Group
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- 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
- KSWOG 1018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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