ID
36444
Descripción
A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01326000 Brief Summary: This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Link
https://clinicaltrials.gov/show/NCT01326000
Palabras clave
Versiones (2)
- 15/1/19 15/1/19 -
- 14/5/19 14/5/19 -
Titular de derechos de autor
Hoffmann-La Roche
Subido en
14 de mayo de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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RO5083945, FOLRIFI and Cetuximab in Colorectal Cancer NCT01326000
Eligibility Criteria
- StudyEvent: Eligibility
Descripción
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Descripción
Prior anti-EGFR treatment
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1443775
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C4055105
Descripción
Prior irinotecan treatment
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0123931
Descripción
The participant should not have had radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief) (if so he is to be excluded)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0279134
- UMLS CUI [1,2]
- C0332185
Descripción
CNS metastasis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0686377
Descripción
Autoimmune disorders
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004364
- UMLS CUI [2,1]
- C0205177
- UMLS CUI [2,2]
- C0004364
Similar models
Eligibility Criteria
- StudyEvent: Eligibility
C0069717 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C1514463 (UMLS CUI [1,2])
C4055105 (UMLS CUI [1,3])
C0123931 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,2])
C0004364 (UMLS CUI [1,2])
C0205177 (UMLS CUI [2,1])
C0004364 (UMLS CUI [2,2])