Gastric CancerPhase 3NCT01813253
Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer
A Phase 3 study testing Irinotecan and Nimotuzumab in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Kuhnil Pharmaceutical Co., Ltd. at 37 sites in 3 countries.
Trial summary
This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- Irinotecan and Nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 37 sitesin 3 countries
- Study dates
- 13 May 2013to 19 Feb 2018
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma.
- Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent and platinum agent.
- Subjects with EGFR overexpression (2+ or 3+ in IHC)
Who cannot join
- Subjects who have received irinotecan
- Subjects who have received EGFR-directed therapy
- Other active malignancy within the last 5 years
Trial locations and contacts
37 sites in 3 countries.
37 sites in 3 countries
Japan23 sites
Study site
Aichi
Study site
Akita
Study site
Aomori
Study site
Chiba, 206-8717
Study site
Ehime
Study site
Fukuoka
Study site
Hiroshima
Study site
Hokkaido
Study site
Hyōgo
Study site
Ishikawa, 920-8530
Study site
Kanagawa
National Cancer Center Hospital East
Kashiwa, Chiba, 277-0882
Study site
Kumamoto
Study site
Kyoto
Study site
Nagano
Study site
Niigata
Study site
Osaka
Study site
Saitama
Study site
Shizuoka, 420-8527
Study site
Shizuoka
Study site
Tochigi
Study site
Tokyo
Study site
Toyama
South Korea9 sites
Study site
Busan
Study site
Daegu
Hwansun Junnam hospital
Gwangju
Study site
Gyeonggi-do
Study site
Incheon
Study site
Jeonju
Study site
Seongnam
Study site
Seoul
Study site
Yangsan
Taiwan5 sites
Study site
Changhua
Study site
Tainan
Study site
Taipei
Study site
Taoyuan
Study site
Thaichung
About this study
Official title: A Randomized, Open-label, Japan-Korea-Taiwan Collaborative Phase 3 Study to Compare the Efficacy of Nimotuzumab and Irinotecan Combination Therapy Versus Irinotecan Monotherapy as Second Line Treatment in Subjects With Advanced or Recurrent Gastric and Gastroesophageal Junction Cancer
This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer.
Read the detailed description
This randomized, open-label, Japan, Korea and Taiwan collaborative, phase 3 study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer. Approximately 400 subjects will be randomized in a 1:1 ratio to receive irinotecan (control group) or nimotuzumab and irinotecan (combination group). Nimotuzumab and/or irinotecan should be continued until disease progression or intolerable toxicity. Nimotuzumab is administered at 400 mg once weekly as an intravenous infusion and irinotecan is administered at 150 mg/m2 once every 2 weeks as an intravenous infusion.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Being tested
- Irinotecan, Nimotuzumab
- Keywords
- epidermal growth factor receptor, second line
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called Boryung irinotecan
150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops
NimotuzumabDrug
Also called DE-766
400mg IV once weekly until progression or unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan and nimotuzumab | Experimental | Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly Receives: Drug: Irinotecan; Drug: Nimotuzumab |
| Irinotecan | Active comparator | Administration of irinotecan 150 mg/m2 IV once every 2 weeks Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of the death from any cause.
Measured: Around 4.5 years after first subject randomization
Secondary outcomes (4)
Progression Free Survival
Progression Free Survival is defined as the time from the date of randomization to the date of progression or death from any cause, whichever comes first.
Measured: Around 4.5 years after first subject randomization
Overall Response Rate
Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response.
Measured: Around 4.5 years after first subject randomization
Disease Control Rate
Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response.
Measured: Around 4.5 years after first subject randomization
Incidence of adverse events
Incidence of adverse events using latest CTCAE version 4 including minor version
Measured: Around 4.5 years after first subject randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study start13 May 2013
- Primary completion19 Feb 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuhnil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813253
- Sponsor's protocol ID
- DE766-A-J302
- Status last verified
- Mar 2018
- First submitted
- 11 Mar 2013
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Japan-Korea-Taiwan Collaborative Phase 3 Study to Compare the Efficacy of Nimotuzumab and Irinotecan Combination Therapy Versus Irinotecan Monotherapy as Second Line Treatment in Subjects With Advanced or Recurrent Gastric and Gastroesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT01813253
- Acronym / sponsor ID
- DE766-A-J302
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Keywords
- epidermal growth factor receptor, second line
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Kuhnil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Study start
- 13 May 2013 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 18 Mar 2013 (estimated)
- 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.
This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer.
Detailed description
This randomized, open-label, Japan, Korea and Taiwan collaborative, phase 3 study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer. Approximately 400 subjects will be randomized in a 1:1 ratio to receive irinotecan (control group) or nimotuzumab and irinotecan (combination group). Nimotuzumab and/or irinotecan should be continued until disease progression or intolerable toxicity. Nimotuzumab is administered at 400 mg once weekly as an intravenous infusion and irinotecan is administered at 150 mg/m2 once every 2 weeks as an intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irinotecan and nimotuzumab | Experimental | Drug: Irinotecan, Drug: NimotuzumabAdminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly |
| Irinotecan | Active comparator | Drug: IrinotecanAdministration of irinotecan 150 mg/m2 IV once every 2 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma.
- Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent and platinum agent.
- Subjects with EGFR overexpression (2+ or 3+ in IHC)
Key exclusion criteria (3 listed)
- Subjects who have received irinotecan
- Subjects who have received EGFR-directed therapy
- Other active malignancy within the last 5 years
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 |
|---|---|---|
| IrinotecanAlso: Boryung irinotecan150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops | Drug | Irinotecan, Irinotecan and nimotuzumab |
| NimotuzumabAlso: DE-766400mg IV once weekly until progression or unacceptable toxicity develops | Drug | Irinotecan and nimotuzumab |
Primary outcome
Overall Survival
Time frame: Around 4.5 years after first subject randomization
Overall survival is defined as the time from the date of randomization to the date of the death from any cause.
4 secondary outcomes
Progression Free Survival
Time frame: Around 4.5 years after first subject randomization
Overall Response Rate
Time frame: Around 4.5 years after first subject randomization
Disease Control Rate
Time frame: Around 4.5 years after first subject randomization
Incidence of adverse events
Time frame: Around 4.5 years after first subject randomization
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irinotecan and Nimotuzumab in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Kuhnil Pharmaceutical Co., Ltd. at 37 sites in 3 countries.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Japan, South Korea, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Around 4.5 years after first subject randomization). 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 26 Mar 2018.