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Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer

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: NCT02501603
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : January 13, 2020
Information provided by (Responsible Party):
Sun Young Rha, Yonsei University

Brief Summary:
For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for target enriched patients in gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastroesophageal Junction Cancer Drug: afatinib Drug: paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Phase II Study of Afatinib Plus Weekly Taxol as Second Line Treatment for Advanced/Recurrent Gastric and Gastroesophageal Junction Cancer
Study Start Date : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: afatinib plus paclitaxel
afatinib plus paclitaxel
Drug: afatinib
Afatinib 40mg daily oral administration

Drug: paclitaxel
Paclitaxel 80mg/m2 IV weekly (day 1,8,15)

Primary Outcome Measures :
  1. compare progression free survival as measured by RECIST 1.1 [ Time Frame: Every 6 weeks until progression, an expected average of 10 months ]
    To identify antitumor activity of afatinib plus weekly taxol(paclitaxel) and explore predictive biomarker

Secondary Outcome Measures :
  1. antitumor efficacy as measured by RECIST 1.1 [ Time Frame: every 6 weeks until progression, an expected average of 10 months ]
  2. safety as measured by CTCAE [ Time Frame: every 3 weeks until progression, an expected average of 10 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
  2. EGFR 2+ or 3+ expression (immunohistochemistry)
  3. ECOG performance status of 0 to 1
  4. Male or female; ≥ 19 years of age
  5. Documented disease progression after one prior therapy, in locally advanced or metastatic setting
  6. patients received last adjuvant chemotherapy less than six months can be enrolled into this study
  7. Her2 positive patients must be progressed after prior trastuzumab based chemotherapy
  8. Subjects with measurable lesion (using RECIST 1.1 criteria)
  9. Subjects who meet the following criteria:

    • Absolute neutrophil count (ANC) ≥ 1000 /µL (*ANC = Neutrophil segs + Neutrophil bands)
    • Platelet count ≥ 80,000/ µL
    • Serum creatinine < 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥50 mL/min using Cockcroft, Gault method
    • AST (SGOT) and ALT (SGPT) : 3 x upper limit of normal (ULN) (If there is Liver Metastasis : 5 x upper limit of normal (ULN))
    • Total bilirubin : 1.5 x upper limit of normal (ULN)
  10. Provision of written informed consent prior to any study procedure

Exclusion Criteria:

  1. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
  2. Any previous chemotherapy or immunotherapy within 2 weeks
  3. Any major operation or irradiation within 4 weeks of baseline disease assessment
  4. Two or more previous systemic cytotoxic chemotherapy (adjuvant chemotherapy is not counted)
  5. Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
  6. Previously taxol(paclitaxel)-exposed patients
  7. Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
  8. Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
  9. Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
  10. Pregnant or lactating female
  11. Patients with contraindicated medication
  12. History of interstitial lung disease (ILD) or presence of ILD on chest X-ray
  13. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

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 identifier (NCT number): NCT02501603

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Contact: Hyo Song Kim 82-2-2228-8124

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Korea, Republic of
Severance Hospital, Yonsei University Health System, Yonsei Cancer Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyosong Kim, M.D    82-2-2228-8124   
Sponsors and Collaborators
Yonsei University
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Principal Investigator: Sun Young Rha Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
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Responsible Party: Sun Young Rha, Professor, Yonsei University Identifier: NCT02501603    
Other Study ID Numbers: 4-2015-0244
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors