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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| afatinib plus paclitaxel | Experimental | afatinib plus paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| afatinib | Drug | Afatinib 40mg daily oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| compare progression free survival as measured by RECIST 1.1 | To identify antitumor activity of afatinib plus weekly taxol(paclitaxel) and explore predictive biomarker | Every 6 weeks until progression, an expected average of 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| antitumor efficacy as measured by RECIST 1.1 | every 6 weeks until progression, an expected average of 10 months | |
| safety as measured by CTCAE | every 3 weeks until progression, an expected average of 10 months |
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Inclusion Criteria:
Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
EGFR 2+ or 3+ expression (immunohistochemistry)
ECOG performance status of 0 to 1
Male or female; ≥ 19 years of age
Documented disease progression after one prior therapy, in locally advanced or metastatic setting
patients received last adjuvant chemotherapy less than six months can be enrolled into this study
Her2 positive patients must be progressed after prior trastuzumab based chemotherapy
Subjects with measurable lesion (using RECIST 1.1 criteria)
Subjects who meet the following criteria:
Provision of written informed consent prior to any study procedure
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Young Rha | Severance Hospital, Yonsei University Health System, Yonsei Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University Health System, Yonsei Cancer Center | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| paclitaxel |
| Drug |
Paclitaxel 80mg/m2 IV weekly (day 1,8,15) |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |