Status:
UNKNOWN
A Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)
Lead Sponsor:
Yonsei University
Conditions:
Inoperable or Recurrent or Metastatic Esophageal Squamous Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 Squamou...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2020
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03770988
Start Date
April 1 2019
End Date
August 31 2020
Last Update
February 22 2019
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea, 03722