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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
| Trial Form Support S.L. | OTHER |
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The clinical hypothesis of this study is that the addition of Panitumumab to the first line treatment combination of docetaxel plus cisplatin will provide benefit to patients with advanced gastric or gastroesophageal junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| panitumumab + docetaxel + cisplatino | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| panitumumab + docetaxel + cisplatino | Drug | Panitumumab, docetaxel and cisplatin combination treatment will be administered for 6 months or until disease progression (PD) according to investigator's criteria unacceptable toxicity or consent withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | To estimate the objective response rate in patients treated with docetaxel, cisplatin and panitumumab as first-line treatment in advanced gastric or gastroesophageal junction adenocarcinoma. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | 3 years | |
| Duration of response | 3 years | |
| Time to response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de A Coruña | A Coruña | La Coruña | 15006 | Spain | ||
| Centro Oncológico de Galícia |
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| 3 years |
| Time to progression | 3 years |
| Time to treatment failure | 3 years |
| Duration of stable disease | 3 years |
| Progression free survival | 3 years |
| Overall survival | 3 years |
| Safety profile | To describe the safety profile of this combination therapy in the 1st-line setting including the incidence of AE's and changes in laboratory parameters. | 3 years |
| Exploratory Objectives | To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints. | 3 years |
| A Coruña |
| La Coruña |
| 15009 |
| Spain |
| Hospital Arquitecto Mercide | Ferrol | La Coruña | 15405 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) | Santiago de Compostela | La Coruña | 15706 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | Lugo | 27003 | Spain |
| Complejo Hospitalario Ourense | Ourense | Ourense | 32005 | Spain |
| Hospital de Pontevedra | Pontevedra | Pontevedra | 36002 | Spain |
| Complejo Hospitalario Universitario de Vigo (Xeral Cies) | Vigo | Pontevedra | 36204 | Spain |
| Policlínica de Vigo S.A. | Vigo | Pontevedra | 36211 | Spain |
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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