Clinical Trials /

Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer

NCT02501603

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 4-2015-0244
  • NCT ID: NCT02501603

Conditions

  • Gastric Cancer
  • Gastroesophageal Junction Cancer

Interventions

DrugSynonymsArms
afatinibafatinib plus paclitaxel
paclitaxelafatinib plus paclitaxel

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
afatinib plus paclitaxelExperimentalafatinib plus paclitaxel
  • afatinib
  • paclitaxel

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:compare progression free survival as measured by RECIST 1.1
Time Frame:Every 6 weeks until progression, an expected average of 10 months
Safety Issue:
Description:To identify antitumor activity of afatinib plus weekly taxol(paclitaxel) and explore predictive biomarker

Secondary Outcome Measures

Measure:antitumor efficacy as measured by RECIST 1.1
Time Frame:every 6 weeks until progression, an expected average of 10 months
Safety Issue:
Description:
Measure:safety as measured by CTCAE
Time Frame:every 3 weeks until progression, an expected average of 10 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Yonsei University

Last Updated

January 10, 2018