Back to resultsEGFR-targeted Therapy for Gastric Cancer
Primary Purpose
Adenocarcinoma of the Stomach
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Anti-EGFR antibody in combination with weekly paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Stomach focused on measuring EGFR
Eligibility Criteria
Key inclusion criteria
- Histologically-proven gastric and gastroesophageal junction adenocarcinoma
- Refractory to first-line chemotherapy for metastatic disease
- Presence of at least 1 measurable lesion according to RECIST version 1.1
- EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining
Key exclusion criteria
1.Prior exposure to taxane or EGFR-targeted therapy
Sites / Locations
- National Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anti-EGFR
Arm Description
Participants will receive GC-1118 in combination with weekly paclitaxel.
Outcomes
Primary Outcome Measures
Response rate
Response rate will be assessed using CT/MRI according to RECIST v1.1.
Secondary Outcome Measures
Progression-free survival
Time from date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed.
Full Information
NCT ID
NCT04077255
First Posted
August 28, 2019
Last Updated
November 29, 2022
Sponsor
National Cancer Center, Korea
Collaborators
Korean Cancer Study Group
1. Study Identification
Unique Protocol Identification Number
NCT04077255
Brief Title
EGFR-targeted Therapy for Gastric Cancer
Official Title
Anti-EGFR Antibody (GC-1118) in Combination With Weekly Paclitaxel as a Second-line Therapy for Gastric and Gastroesophageal Junction Adenocarcinomas With Amplifications
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Korean Cancer Study Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Based on targeted NGS panel results, metastatic gastric cancer patients with gene amplifications will receive either anti-EGFR antibody (GC-1118) in combination with weekly paclitaxel as a second-line therapy.
Detailed Description
Participants will receive each treatment if the gastric cancer tissue sample reveals either EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Stomach
Keywords
EGFR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anti-EGFR
Arm Type
Experimental
Arm Description
Participants will receive GC-1118 in combination with weekly paclitaxel.
Intervention Type
Drug
Intervention Name(s)
Anti-EGFR antibody in combination with weekly paclitaxel
Other Intervention Name(s)
GC-1118 in combination with weekly paclitaxel
Intervention Description
Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy
Primary Outcome Measure Information:
Title
Response rate
Description
Response rate will be assessed using CT/MRI according to RECIST v1.1.
Time Frame
Response rate will be assessed at 8 weeks.
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Time from date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed.
Time Frame
From date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed up to 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion criteria
Histologically-proven gastric and gastroesophageal junction adenocarcinoma
Refractory to first-line chemotherapy for metastatic disease
Presence of at least 1 measurable lesion according to RECIST version 1.1
EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining
Key exclusion criteria
1.Prior exposure to taxane or EGFR-targeted therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hark K Kim, M.D.,Ph.D
Phone
+82-31-920-2238
Email
hkim@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hark K Kim, M.D.,Ph.D
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hark K Kim, MD,PhD
Phone
+82-31-920-2238
Email
hkim@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Hyegyung Chang, RN
Phone
+82-31-920-2233
Email
jhk@ncc.re.kr
12. IPD Sharing Statement
Plan to Share IPD
No
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EGFR-targeted Therapy for Gastric Cancer
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