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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012656-25 |
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This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is <50.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5083945 | Drug | 700mg iv weekly |
| |
| cetuximab |
| Measure | Description | Time Frame |
|---|---|---|
| immune cell infiltration head and neck squamous cell cancer (HNSCC) | through study completion or early study discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels | through study completion or early study discontinuation | |
| safety and efficacy: AEs, laboratory parameters, tumour assessments | through study completion or early study discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toulouse | 31059 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28950289 | Derived | Temam S, Spicer J, Farzaneh F, Soria JC, Oppenheim D, McGurk M, Hollebecque A, Sarini J, Hussain K, Soehrman Brossard S, Manenti L, Evers S, Delmar P, Di Scala L, Mancao C, Feuerhake F, Andries L, Ott MG, Passioukov A, Delord JP. An exploratory, open-label, randomized, multicenter study to investigate the pharmacodynamics of a glycoengineered antibody (imgatuzumab) and cetuximab in patients with operable head and neck squamous cell carcinoma. Ann Oncol. 2017 Nov 1;28(11):2827-2835. doi: 10.1093/annonc/mdx489. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C569293 | imgatuzumab |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses |
|
| Villejuif |
| 94805 |
| France |
| Milan | Lombardy | 20162 | Italy |
| Nijmegen | 6525 GA | Netherlands |
| Barcelona | Barcelona | 08035 | Spain |
| Seville | Sevilla | 41013 | Spain |
| London | SE1 9RT | United Kingdom |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |