NCT04077255

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

4.3 years

First QC Date

August 28, 2019

Last Update Submit

November 29, 2022

Conditions

Adenocarcinoma of the Stomach

Keywords

EGFR

Outcome Measures

Primary Outcomes (1)

  • Response rate

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

    Response rate will be assessed at 8 weeks.

Secondary Outcomes (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.

Study Arms (1)

anti-EGFR

EXPERIMENTAL

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

Drug: Anti-EGFR antibody in combination with weekly paclitaxel

Interventions

Anti-EGFR antibody in combination with weekly paclitaxelDRUG

Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy

Also known as: GC-1118 in combination with weekly paclitaxel
anti-EGFR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior exposure to taxane or EGFR-targeted therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

MeSH Terms

Interventions

GC1118

Study Officials

  • Hark K Kim, M.D.,Ph.D

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hark K Kim, M.D.,Ph.D

CONTACT

+82-31-920-2238hkim@ncc.re.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2019

First Posted

September 4, 2019

Study Start

September 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

November 30, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)