Inoperable or Recurrent or Metastatic Esophageal Squamous CarcinomaPhase 2NCT03770988
A Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)
A Phase 2 study testing Treatment with Poziotinib in people with Inoperable or Recurrent or Metastatic Esophageal Squamous Carcinoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Esophageal cancer is the sixth most common cause of cancer deaths worldwide. Esophageal adenocarcinoma has become more common in Western countries. In many Asian countries, however, Esophageal Squamous Cell Carcinoma (ESCC) represents the most common esophageal cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Inoperable or Recurrent or Metastatic Esophageal Squamous Carcinoma
- What is being tested?
- Treatment with Poziotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2019to 31 Aug 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed esophageal squamous cell carcinoma (Includes cases with pathologic findings with clinical course comparable to squamous cell carcinoma. For example, undifferentiated carcinoma)
- Diseases that can not achieve curative aim with radical surgery, radiation, or chemo-radiotherapy. Previous palliative chemotherapy including platinum-based agents for advanced or recurrent esophageal squamous cell carcinoma (If the disease progresses within 6 months after the curative platinum-based chemotherapy or disease progresses within 6 months after last adjuvant chemotherapy, it is considered to be the previous palliative chemotherapy.
- Have measurable disease based on RECIST 1.1.
- Be 20 years of age on day of signing informed consent.
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
- Demonstrate adequate organ function
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- Absolute Neutrophil Count ≥ 1500/μL
- Platelet Count ≥100,000/μL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤
- Serum bilirubin ≤ 1.5 x ULN
- AST, ALT ≤ 1.5 x ULN (with liver metastasis ≤ 5.0 x ULN)
- Be willing and able to provide written informed consent/assent for the trial.
Who cannot join
- Without measurable lesion based on RECIST 1.1
- Has received prior therapy with EGFR/HER2 directed therapy.
- Has history of intestinal obstruction or recent bleeding (subjects with clinically significant hemorrhagic or clotting events within the past 6 months)
- Pregnant or lactating women
- Women who have not received a baseline pregnancy test or have a positive result. (A woman who has not undergone a previous hysterectomy, or history of amenorrhea of more than 12 months, or undergone bilateral oophorectomy is considered to be a non-pregnant menopausal woman.)
- Male or reproductive women who are not willing to use contraception during the trial
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- Has a known additional malignancy that is progressing or requires active treatment within 3 years. (Except skin basal cell carcinoma, cervix epithelial carcinoma in situ, Superficial bladder cancer)
- Subjective who is likely to interfere with the understanding of the written consent or influence the compliance of the trial medication. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disorders that are considered clinically significant by the investigator
- Has stable LVEF of less than 50%
- Received organ transplants that require immunosuppressive therapy
- Has un-controlled active infectious disease.
- Has symptomatic central nerve system metastasis (Except in case of discontinuation of corticosteroids at least 2 weeks before clinical trials and radiologic and neurologically stable cases over 4 weeks)
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has New York Heart Association, NYHA class III or IV Heart failure, un-controlled hypertension
- Experienced unstable angina or myocardial infarction within the last 6 months
- Has un-controlled arrhythmia or judged to have clinically significant cardiovascular abnormalities by investigators
- Incapability of Oral ingestion and digestion.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital
Seoul, 03722
Hye Ryun Kim, MD, 82 2 2228 8125, nobleg@yuhs.ac
About this study
Official title: A Single Arm Phase II Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)
Esophageal cancer is the sixth most common cause of cancer deaths worldwide. Esophageal adenocarcinoma has become more common in Western countries. In many Asian countries, however, Esophageal Squamous Cell Carcinoma (ESCC) represents the most common esophageal cancer. In palliative chemotherapy for metastatic or recurrent ESCC, A combination of 5-fluorouracil and platinum was prescribed as a standard treatment for about 20 years. With this traditional regimen, the median progression free survival is approximately 7 months, and 1-year survival rate is reported to be 34%. Combinations of taxane and anthracycline are also considerable, but also shows the median survival less than one year. Though cytotoxic chemotherapy is current main treatment option, molecularly targeted agents are recently incorporated to improve survival in ESCC. There is a strong rationale for investigation of biologic agents targeting Epithelial Growth Factor Receptor (EGFR) family in ESCC. EGFR is frequently overexpressed in esophageal cancer and is known to be associated with poor prognosis. Several EGFR tyrosine kinase inhibitors (TKIs) have been studied in esophageal cancer subjects and have shown clinical effects. In a recent Phase II trial using dacomitinib, pan-human epidermal growth receptor TKI, Partial response was observed in 10 of the 49 esophageal cancer subjects, with a response rate of 20.8%.
Based on notable rationale in exploring impact of EGFR inhibition, we suggest multicenter phase II study to determine antitumor activity and safety of a other potent pan-HER inhibitor, Poziotinib in Esophageal Squamous cell carcinoma.
- Being tested
- Treatment with Poziotinib
- Keywords
- esophageal squamous carcinoma, poziotinib, pan-HER inhibitor
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with PoziotinibDrug
Treatment with Poziotinib
| Study group | Role | What they receive |
|---|---|---|
| poziotinib single arm study | Experimental | Single Arm study Receives: Drug: Treatment with Poziotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate using RECIST 1.1
Measured: every 8 weeks, assessed up to 100 weeks
Secondary outcomes (4)
Overall Survival
Measured: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 months
Progression Free Survival
Measured: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 months
Duration of Response
Measured: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 months
Safety assessed by incidence of treatment-emergent adverse events
To evaluate the safety of Poziotinib, pan HER inhibitor in recurrent/metastatic esophageal cancer
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Apr 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable or Recurrent or Metastatic Esophageal Squamous CarcinomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770988
- Sponsor's protocol ID
- 4-2017-1193
- Status last verified
- Feb 2019
- First submitted
- 14 Aug 2018
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)
- ClinicalTrials.gov ID
- NCT03770988
- Acronym / sponsor ID
- 4-2017-1193
- Keywords
- esophageal squamous carcinoma, poziotinib, pan-HER inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 10 Dec 2018 (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.
Esophageal cancer is the sixth most common cause of cancer deaths worldwide. Esophageal adenocarcinoma has become more common in Western countries. In many Asian countries, however, Esophageal Squamous Cell Carcinoma (ESCC) represents the most common esophageal cancer. In palliative chemotherapy for metastatic or recurrent ESCC, A combination of 5-fluorouracil and platinum was prescribed as a standard treatment for about 20 years. With this traditional regimen, the median progression free survival is approximately 7 months, and 1-year survival rate is reported to be 34%. Combinations of taxane and anthracycline are also considerable, but also shows the median survival less than one year. Though cytotoxic chemotherapy is current main treatment option, molecularly targeted agents are recently incorporated to improve survival in ESCC. There is a strong rationale for investigation of biologic agents targeting Epithelial Growth Factor Receptor (EGFR) family in ESCC. EGFR is frequently overexpressed in esophageal cancer and is known to be associated with poor prognosis. Several EGFR tyrosine kinase inhibitors (TKIs) have been studied in esophageal cancer subjects and have shown clinical effects. In a recent Phase II trial using dacomitinib, pan-human epidermal growth receptor TKI, Partial response was observed in 10 of the 49 esophageal cancer subjects, with a response rate of 20.8%.
Based on notable rationale in exploring impact of EGFR inhibition, we suggest multicenter phase II study to determine antitumor activity and safety of a other potent pan-HER inhibitor, Poziotinib in Esophageal Squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| poziotinib single arm study | Experimental | Drug: Treatment with PoziotinibSingle Arm study |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed esophageal squamous cell carcinoma (Includes cases with pathologic findings with clinical course comparable to squamous cell carcinoma. For example, undifferentiated carcinoma)
- Diseases that can not achieve curative aim with radical surgery, radiation, or chemo-radiotherapy. Previous palliative chemotherapy including platinum-based agents for advanced or recurrent esophageal squamous cell carcinoma (If the disease progresses within 6 months after the curative platinum-based chemotherapy or disease progresses within 6 months after last adjuvant chemotherapy, it is considered to be the previous palliative chemotherapy.
- Have measurable disease based on RECIST 1.1.
- Be 20 years of age on day of signing informed consent.
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
Key exclusion criteria (17 listed)
- Without measurable lesion based on RECIST 1.1
- Has received prior therapy with EGFR/HER2 directed therapy.
- Has history of intestinal obstruction or recent bleeding (subjects with clinically significant hemorrhagic or clotting events within the past 6 months)
- Pregnant or lactating women
- Women who have not received a baseline pregnancy test or have a positive result. (A woman who has not undergone a previous hysterectomy, or history of amenorrhea of more than 12 months, or undergone bilateral oophorectomy is considered to be a non-pregnant menopausal woman.)
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 |
|---|---|---|
| Treatment with PoziotinibTreatment with Poziotinib | Drug | poziotinib single arm study |
Primary outcome
Objective Response Rate
Time frame: every 8 weeks, assessed up to 100 weeks
Objective Response Rate using RECIST 1.1
4 secondary outcomes
Overall Survival
Time frame: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 months
Progression Free Survival
Time frame: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 months
Duration of Response
Time frame: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 months
Safety assessed by incidence of treatment-emergent adverse events
Time frame: up to 100 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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.
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 Treatment with Poziotinib in people with Inoperable or Recurrent or Metastatic Esophageal Squamous Carcinoma, run by Yonsei University 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 13 inclusion and 17 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 22 Feb 2019. 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 Hye Ryun Kim, MD (82 2 2228 8125, nobleg@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: every 8 weeks, assessed up to 100 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 22 Feb 2019.