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A Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03770988
Recruitment Status : Not yet recruiting
First Posted : December 10, 2018
Last Update Posted : February 22, 2019
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE August 14, 2018
First Posted Date  ICMJE December 10, 2018
Last Update Posted Date February 22, 2019
Estimated Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
Objective Response Rate [ Time Frame: every 8 weeks, assessed up to 100 weeks ]
Objective Response Rate using RECIST 1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03770988 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
  • 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 ]
    To evaluate the safety of Poziotinib, pan HER inhibitor in recurrent/metastatic esophageal cancer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)
Official Title  ICMJE A Single Arm Phase II Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Inoperable or Recurrent or Metastatic Esophageal Squamous Carcinoma
Intervention  ICMJE Drug: Treatment with Poziotinib
Treatment with Poziotinib
Study Arms  ICMJE Experimental: poziotinib single arm study
Single Arm study
Intervention: Drug: Treatment with Poziotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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.
  3. Have measurable disease based on RECIST 1.1.
  4. Be 20 years of age on day of signing informed consent.
  5. Performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
  6. Demonstrate adequate organ function
  7. Absolute Neutrophil Count ≥ 1500/μL
  8. Platelet Count ≥100,000/μL
  9. Hemoglobin ≥ 9.0 g/dL
  10. Serum creatinine ≤
  11. Serum bilirubin ≤ 1.5 x ULN
  12. AST, ALT ≤ 1.5 x ULN (with liver metastasis ≤ 5.0 x ULN)
  13. Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria:

  1. Without measurable lesion based on RECIST 1.1
  2. Has received prior therapy with EGFR/HER2 directed therapy.
  3. Has history of intestinal obstruction or recent bleeding (subjects with clinically significant hemorrhagic or clotting events within the past 6 months)
  4. Pregnant or lactating women
  5. 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.)
  6. Male or reproductive women who are not willing to use contraception during the trial
  7. 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)
  8. 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
  9. Has stable LVEF of less than 50%
  10. Received organ transplants that require immunosuppressive therapy
  11. Has un-controlled active infectious disease.
  12. 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)
  13. Has known history of, or any evidence of active, non-infectious pneumonitis.
  14. Has New York Heart Association, NYHA class III or IV Heart failure, un-controlled hypertension
  15. Experienced unstable angina or myocardial infarction within the last 6 months
  16. Has un-controlled arrhythmia or judged to have clinically significant cardiovascular abnormalities by investigators
  17. Incapability of Oral ingestion and digestion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hye Ryun Kim, MD 82 2 2228 8125
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03770988
Other Study ID Numbers  ICMJE 4-2017-1193
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP