A single arm phase II trial to evaluate the efficacy of Poziotinib, pan HER inhibitor in recurrent/metastatic esophageal cancer

Not Applicable

Withdrawn

Conditions: Neoplasms

Registration Number: KCT0003833

Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: All

Target Recruitment: 49

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
•Serum creatinine = 1.5 x ULN (Upper limit of normal)
•Serum bilirubin = 1.5 x ULN Upper limit of normal)
•AST, ALT = 3.0 x ULN (Upper limit of normal) with liver metastasis = 5.0 x ULN(Upper limit of normal))
8. Be willing and able to provide written informed consent/assent for the trial.
9. Subjects who understand that they have the right to sign a written consent form prior to participation in the clinical trial or to withdraw consent form participation in the clinical trial without disadvantage at any time.

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%.
11. Received organ transplants that require immunosuppressive therapy.
12. Subjects who have uncontrolled active infectious disease.
13. Subjects who have 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).
14. Subjects who have existing interstitial lung disease.
15. Subjects with class III or IV heart failure by the New York Heart Association (NYHA) classification, subjects with uncontrolled hypertension, unstable angina or myocardial infarction within the last 6 months, subjects with poorly controlled cardiac arrhythmia, or subjects was judged to have clinically significant cardiovascular abnormalities by the investigator.
16. Incapability of oral ingestion and digestion.