KCT0003833
Withdrawn
未知
A single arm phase II trial to evaluate the efficacy of Poziotinib, pan HER inhibitor in recurrent/metastatic esophageal cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 49
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically confirmed esophageal squamous cell carcinoma (includes cases with pathologic findings with clinical course comparable to squamous cell carcinoma. For example, undifferentiated carcinoma).
- •2\. Diseases that can not achieve curative aim with radical surgery, radiation, or chemo\-radiotherapy.
- •3\. 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.
- •4\. Have measurable disease based on RECIST(Response evaluation criteria in solid tumors) 1\.1\.
- •5\. Age \> 20 years at time of study entry.
- •6\. Performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
- •7\. Demonstrate adequate organ function.
- •Absolute Neutrophil Count \= 1500/µL
- •Platelet Count \=100,000/µL
- •Hemoglobin \= 9\.0 g/dL
Exclusion Criteria
- •1\. Without measurable lesion based on RECIST(Response evaluation criteria in solid tumors) 1\.1\.
- •2\. Has received prior therapy with EGFR/HER2(Epidermal growth factor receptor/human epidermal growth factor receptor 2\) directed therapy.
- •3\. Subjects who underwent major surgery requiring general anesthesia within 4 weeks before enrollment.
- •4\. Has history of intestinal obstruction or recent bleeding (subjects with clinically significant hemorrhagic or clotting events within the past 6 months).
- •5\. Pregnant or lactating women.
- •6\. 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).
- •7\. Male or reproductive women who are not willing to use contraception during the trial.
- •8\. 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).
- •9\. Subjects who interfere with the understanding of the written consent or are likely to affect the compliance of the trial medication, patients with uncontrolled seizures, central nervous system disorders or psychiatric disorders that are considered clinically significant by the investigator.
- •10\. Subjects who have stable LVEF of less than 50%.
Outcomes
Primary Outcomes
Not specified
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