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EGFR-targeted Therapy for Gastric Cancer

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Recruiting
CT.gov ID
NCT04077255
Collaborator
Korean Cancer Study Group (Other)
38
Enrollment
1
Location
1
Arm
52
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anti-EGFR antibody in combination with weekly paclitaxel
 Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: anti-EGFR

Participants will receive GC-1118 in combination with weekly paclitaxel.

Drug: Anti-EGFR antibody in combination with weekly paclitaxel
Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy
Other Names:
  • GC-1118 in combination with weekly paclitaxel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response rate [Response rate will be assessed at 8 weeks.]

      Response rate will be assessed using CT/MRI according to RECIST v1.1.

    Secondary Outcome Measures

    1. Progression-free survival [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.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Key inclusion criteria

    1. Histologically-proven gastric and gastroesophageal junction adenocarcinoma

    2. Refractory to first-line chemotherapy for metastatic disease

    3. Presence of at least 1 measurable lesion according to RECIST version 1.1

    4. EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

    Key exclusion criteria

    1.Prior exposure to taxane or EGFR-targeted therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center Goyang Gyeonggi Korea, Republic of 10408

    Sponsors and Collaborators

    • National Cancer Center, Korea
    • Korean Cancer Study Group

    Investigators

    • Principal Investigator: Hark K Kim, M.D.,Ph.D, National Cancer Center, Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hark Kyun Kim, Principal Investigator, National Cancer Center, Korea
    ClinicalTrials.gov Identifier:
    NCT04077255
    Other Study ID Numbers:
    • 31973
    First Posted:
    Sep 4, 2019
    Last Update Posted:
    May 14, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Hark Kyun Kim, Principal Investigator, National Cancer Center, Korea
    EGFR
    Additional relevant MeSH terms:
    Adenocarcinoma
    Paclitaxel
    Albumin-Bound Paclitaxel
    Antibodies

    Study Results

    No Results Posted as of May 14, 2021