ID
36444
Beskrivning
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.
Länk
https://clinicaltrials.gov/show/NCT01326000
Nyckelord
Versioner (2)
- 2019-01-15 2019-01-15 -
- 2019-05-14 2019-05-14 -
Rättsinnehavare
Hoffmann-La Roche
Uppladdad den
14 maj 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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RO5083945, FOLRIFI and Cetuximab in Colorectal Cancer NCT01326000
Eligibility Criteria
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Beskrivning
Prior anti-EGFR treatment
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1443775
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C4055105
Beskrivning
Prior irinotecan treatment
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0123931
Beskrivning
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)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0279134
- UMLS CUI [1,2]
- C0332185
Beskrivning
CNS metastasis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0686377
Beskrivning
Autoimmune disorders
Datatyp
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])