ID
36444
Description
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
Keywords
Versions (2)
- 1/15/19 1/15/19 -
- 5/14/19 5/14/19 -
Copyright Holder
Hoffmann-La Roche
Uploaded on
May 14, 2019
DOI
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License
Creative Commons BY-NC 3.0
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RO5083945, FOLRIFI and Cetuximab in Colorectal Cancer NCT01326000
Eligibility Criteria
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Description
Prior anti-EGFR treatment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1443775
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C4055105
Description
Prior irinotecan treatment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0123931
Description
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)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0279134
- UMLS CUI [1,2]
- C0332185
Description
CNS metastasis
Data type
boolean
Alias
- UMLS CUI [1]
- C0686377
Description
Autoimmune disorders
Data type
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])