Adenocarcinoma of the StomachPhase 2NCT04077255
EGFR-targeted Therapy for Gastric Cancer
A Phase 2 study testing Anti-EGFR antibody in combination with weekly paclitaxel in people with Adenocarcinoma of the Stomach, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Stomach
- What is being tested?
- Anti-EGFR antibody in combination with weekly paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2019to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1.Prior exposure to taxane or EGFR-targeted therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Hark K Kim, MD,PhD, +82-31-920-2238, hkim@ncc.re.kr
Hyegyung Chang, RN, +82-31-920-2233, jhk@ncc.re.kr
About this study
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
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.
Read the 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
- Conditions
- Adenocarcinoma of the Stomach
- Being tested
- Anti-EGFR antibody in combination with weekly paclitaxel
- Keywords
- EGFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-EGFR antibody in combination with weekly paclitaxelDrug
Also called GC-1118 in combination with weekly paclitaxel
Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy
| Study group | Role | What they receive |
|---|---|---|
| anti-EGFR | Experimental | Participants will receive GC-1118 in combination with weekly paclitaxel. Receives: Drug: Anti-EGFR antibody in combination with weekly paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response rate will be assessed using CT/MRI according to RECIST v1.1.
Measured: Response rate will be assessed at 8 weeks.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the StomachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Korean Cancer Study Group
- Responsible party
- Principal investigator, Hark Kyun Kim, National Cancer Center, Korea
- Investigators
- Hark K Kim, M.D.,Ph.D, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077255
- Sponsor's protocol ID
- 31973
- Status last verified
- Nov 2022
- First submitted
- 28 Aug 2019
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04077255
- Acronym / sponsor ID
- 31973
- Conditions
- Adenocarcinoma of the Stomach
- Keywords
- EGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Korean Cancer Study Group
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-EGFR | Experimental | Drug: Anti-EGFR antibody in combination with weekly paclitaxelParticipants will receive GC-1118 in combination with weekly paclitaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 listed)
- 1.Prior exposure to taxane or EGFR-targeted therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-EGFR antibody in combination with weekly paclitaxelAlso: GC-1118 in combination with weekly paclitaxelIntravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy | Drug | anti-EGFR |
Primary outcome
Response rate
Time frame: Response rate will be assessed at 8 weeks.
Response rate will be assessed using CT/MRI according to RECIST v1.1.
1 secondary outcome
Progression-free survival
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hark K Kim, M.D.,Ph.D principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-EGFR antibody in combination with weekly paclitaxel in people with Adenocarcinoma of the Stomach, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hark K Kim, M.D.,Ph.D (+82-31-920-2238, hkim@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Response rate will be assessed at 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.