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. 1/15/19 1/15/19 -
  2. 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

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the patient 18 years old or older?
Description

Participants should be adult patients >/= 18 years of age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Does the participant have a carcinoma of the colon and/or rectum?
Description

The participant has to have carcinoma of the colon and/or rectum

Data type

boolean

Alias
UMLS CUI [1]
C0009402
Does the patient have disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease?
Description

Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0069717
Does the participant have an ecog performance status of 0-1?
Description

The participant should have an ecog performance status of 0-1

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Does the participant have adequate hematological, renal and liver function?
Description

The participanthas to have adequate hematological, renal and liver function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Did the participant have prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (egfr)?
Description

Prior anti-EGFR treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1443775
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C4055105
Did the participant have prior treatment with irinotecan?
Description

Prior irinotecan treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0123931
Did the participant have radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief)?
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
Does the participant have a CNS metastasis?
Description

CNS metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0686377
Does the participant have a history of or an active autoimmune disorder(s)/condition(s)?
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
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Is the patient 18 years old or older?
boolean
C0001779 (UMLS CUI [1])
Colorectal carcinoma
Item
Does the participant have a carcinoma of the colon and/or rectum?
boolean
C0009402 (UMLS CUI [1])
Disease Progression
Item
Does the patient have disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease?
boolean
C0242656 (UMLS CUI [1,1])
C0069717 (UMLS CUI [1,2])
ECOG Performance Status
Item
Does the participant have an ecog performance status of 0-1?
boolean
C1520224 (UMLS CUI [1])
Hematological, Renal and Liver Function
Item
Does the participant have adequate hematological, renal and liver function?
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Prior anti-EGFR treatment
Item
Did the participant have prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (egfr)?
boolean
C1443775 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C4055105 (UMLS CUI [1,3])
Prior irinotecan treatment
Item
Did the participant have prior treatment with irinotecan?
boolean
C1514463 (UMLS CUI [1,1])
C0123931 (UMLS CUI [1,2])
Prior Radiotherapy
Item
Did the participant have radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief)?
boolean
C0279134 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
CNS metastasis
Item
Does the participant have a CNS metastasis?
boolean
C0686377 (UMLS CUI [1])
Autoimmune disorders
Item
Does the participant have a history of or an active autoimmune disorder(s)/condition(s)?
boolean
C0262926 (UMLS CUI [1,1])
C0004364 (UMLS CUI [1,2])
C0205177 (UMLS CUI [2,1])
C0004364 (UMLS CUI [2,2])
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