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

February 20, 2019 updated by: Yonsei University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: poziotinib single arm study
Single Arm study
Drug: Treatment with Poziotinib
Treatment with Poziotinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: every 8 weeks, assessed up to 100 weeks
Objective Response Rate using RECIST 1.1
every 8 weeks, assessed up to 100 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 months
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
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
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
up to 100 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

August 31, 2020

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-1193

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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