ID
36444
Beschrijving
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
Trefwoorden
Versies (2)
- 15-01-19 15-01-19 -
- 14-05-19 14-05-19 -
Houder van rechten
Hoffmann-La Roche
Geüploaded op
14 mei 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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RO5083945, FOLRIFI and Cetuximab in Colorectal Cancer NCT01326000
Eligibility Criteria
- StudyEvent: Eligibility
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Beschrijving
Prior anti-EGFR treatment
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1443775
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C4055105
Beschrijving
Prior irinotecan treatment
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0123931
Beschrijving
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)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0279134
- UMLS CUI [1,2]
- C0332185
Beschrijving
CNS metastasis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0686377
Beschrijving
Autoimmune disorders
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004364
- UMLS CUI [2,1]
- C0205177
- UMLS CUI [2,2]
- C0004364
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Eligibility Criteria
- StudyEvent: Eligibility
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