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
NCT ID: NCT01326000
Last Updated: 2022-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
169 participants
INTERVENTIONAL
2011-04-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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KRAS WT A
FOLFIRI
standard iv chemotherapy
RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
KRAS WT B
FOLFIRI
standard iv chemotherapy
cetuximab
400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
KRAS mutant A
FOLFIRI
standard iv chemotherapy
RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
KRAS mutant B
FOLFIRI
standard iv chemotherapy
Interventions
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FOLFIRI
standard iv chemotherapy
RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
cetuximab
400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
Eligibility Criteria
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Inclusion Criteria
* Carcinoma of the colon and/or rectum
* Disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease
* ECOG performance status 0-1
* Adequate hematological, renal and liver function
Exclusion Criteria
* Prior treatment with irinotecan
* Radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief)
* CNS metastasis
* History of or active autoimmune disorders/conditions
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Encinitas, California, United States
Highland, California, United States
La Jolla, California, United States
La Verne, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
Harvey, Illinois, United States
Skokie, Illinois, United States
Skokie, Illinois, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Sayre, Pennsylvania, United States
Greenville, South Carolina, United States
Memphis, Tennessee, United States
Newcastle, New South Wales, Australia
Port Macquarie, New South Wales, Australia
Adelaide, South Australia, Australia
Box Hill, Victoria, Australia
EAST Bentleigh, Victoria, Australia
Frankston, Victoria, Australia
Brussels, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Bordeaux, , France
Brest, , France
Lille, , France
Paris, , France
Saint-Herblain, , France
Toulouse, , France
Essen, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Herne, , Germany
Regensburg, , Germany
Napoli, Campania, Italy
Bologna, Emilia-Romagna, Italy
Udine, Friuli Venezia Giulia, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Olsztyn, , Poland
Szczecin, , Poland
Sabadell, Barcelona, Barcelona, Spain
Santander, Cantabria, Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Seville, , Spain
Valencia, , Spain
Aberdeen, , United Kingdom
Belfast, , United Kingdom
Bournemouth, , United Kingdom
Cardiff, , United Kingdom
Dorchester, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Northwood, , United Kingdom
Romford, , United Kingdom
Weston-super-Mare, , United Kingdom
Countries
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Other Identifiers
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BP25438
Identifier Type: -
Identifier Source: org_study_id
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