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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940976
Recruitment Status : Unknown
Verified June 2019 by Shen Lin, Peking University.
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Afatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Afatinib in Previously Treated Recurrent or Metastasic Esophageal Squamous Cell Carcinoma With EGFR Overexpression or EGFR Amplification (ESCC-A01)
Actual Study Start Date : April 28, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Afatinib Drug: Afatinib
Afatinib is orally administered at 40mg Qd of each 28 day cycle.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. Progression free survival [ Time Frame: Up to 2 years ]
    Measure of time from study treatment to disease progression or death

  4. Overall survival [ Time Frame: Up to 2 years ]
    Measure of time from study treatment to patient's death or lost to follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940976


Locations
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China, Beijing
Peking University Cancer Hospital and Institute
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Lin Shen, Professor Peking University Cancer Hospital and Institute
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Responsible Party: Shen Lin, Clinical Professor, Peking University
ClinicalTrials.gov Identifier: NCT03940976    
Other Study ID Numbers: ESCC-A01
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shen Lin, Peking University:
afatinib
EGFR Overexpression
EGFR Amplification
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action