Afatinib in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification (ESCC-A01)

June 9, 2019 updated by: Shen Lin, Peking University

Phase 2 Study of Afatinib in Previously Treated Recurrent or Metastasic Esophageal Squamous Cell Carcinoma With EGFR Overexpression or EGFR Amplification (ESCC-A01)

This is a phase 2 trial investigating the effect and safety of afatinib in previously treated recurrent or metastasic esophageal squamous cell carcinoma with EGFR overexpression or EGFR amplification.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Peking University Cancer Hospital and Institute

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Having signed informed consent.
  2. Age 18 to 70 years old.
  3. Histologically confirmed esophageal squamous carcinoma
  4. Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification.
  5. Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed unresectable metastasic or recurrent ESCC.
  6. Refractory or intolerant to at least one regimen.
  7. Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 21 days before enrollment)
  8. Life expectancy of ≥3 month
  9. Eastern Cooperative Oncology Group (ECOG) 0-2
  10. WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>100,000/mm3, Hb>9g/dl，Bilirubin level < 1.5 times ULN，Serum creatinine <1.5 times ULN，ALT and AST<2.5 times ULN ，AKP < 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
  11. No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃.
  12. Good compliance

Exclusion Criteria:

  1. Contraindications of afatinib.
  2. Unable to take afatinib orally because of esophageal stenosis.
  3. Currently receiving other effective regimens.
  4. Previous anticipate other clinical trial within 4 weeks before entering this study.
  5. No measurable lesions, eg. pleural fluid and ascites.
  6. With other malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ.
  7. Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months.
  8. Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis.
  9. HIV infection, active hepatitis B or hepatitis C.
  10. Unstable systemic diseases such as poorly controlled diabetes.
  11. Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT.
  12. Keratitis, ulcerative keratitis or severe dry eye syndrome. Known hypersensitivity to study drug.
  13. Pregnancy or lactation period.
  14. Active severe infection within 14 days.

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: Afatinib
Drug: Afatinib
Afatinib is orally administered at 40mg Qd of each 28 day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Percentage of patients who achieve partial response (PR) or complete response (CR) or stable disease (SD) based on Response Evaluation Criteria In Solid Tumors (RECIST).
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Overall survival
Time Frame: Up to 2 years
Measure of time from study treatment to patient's death or lost to follow-up.
Up to 2 years
Incidence of Treatment-Related Adverse Events
Time Frame: Until 30 days after the last treatment
Number of adverse events of afatinib in patients with ESCC.
Until 30 days after the last treatment
Progression free survival
Time Frame: Up to 2 years
Measure of time from study treatment to disease progression or death
Up to 2 years

Collaborators and Investigators

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

Sponsor

Peking University

Investigators

  • Principal Investigator: Lin Shen, Professor, Peking University Cancer Hospital and Institute

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 (Actual)

April 28, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

April 28, 2019

First Submitted That Met QC Criteria

May 5, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 9, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCC-A01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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