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
A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer
1 other identifier
interventional
169
9 countries
69
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Apr 2011
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2011
CompletedFirst Posted
Study publicly available on registry
March 30, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedNovember 17, 2022
November 1, 2022
2.7 years
March 29, 2011
November 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
approximately 18 months
Secondary Outcomes (6)
Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria
approximately 18 months
Duration of response: time from complete or partial response to disease progression or death
approximately 18 months
Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria
approximately 18 months
Overall survival
approximately 18 months
Safety: Incidence of adverse events
approximately 18 months
- +1 more secondary outcomes
Study Arms (4)
KRAS WT A
EXPERIMENTALKRAS WT B
ACTIVE COMPARATORKRAS mutant A
EXPERIMENTALKRAS mutant B
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, \>/= 18 years of age
- 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
You may not qualify if:
- Prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (EGFR)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Unknown Facility
Encinitas, California, 92024, United States
Unknown Facility
Highland, California, 92346, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
La Verne, California, 91750, United States
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Harvey, Illinois, 60426, United States
Unknown Facility
Skokie, Illinois, 60076, United States
Unknown Facility
Skokie, Illinois, 60077, United States
Unknown Facility
Charlotte, North Carolina, 28204, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Sayre, Pennsylvania, 18840, United States
Unknown Facility
Greenville, South Carolina, 29615, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
Newcastle, New South Wales, 2298, Australia
Unknown Facility
Port Macquarie, New South Wales, 2444, Australia
Unknown Facility
Adelaide, South Australia, 5041, Australia
Unknown Facility
Box Hill, Victoria, 3128, Australia
Unknown Facility
EAST Bentleigh, Victoria, VIC 3165, Australia
Unknown Facility
Frankston, Victoria, 3199, Australia
Unknown Facility
Brussels, 1000, Belgium
Unknown Facility
Brussels, 1200, Belgium
Unknown Facility
Edegem, 2650, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Bordeaux, 33075, France
Unknown Facility
Brest, 29200, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Saint-Herblain, 44805, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Essen, 45122, Germany
Unknown Facility
Hamburg, 20246, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Heidelberg, 69120, Germany
Unknown Facility
Herne, 44625, Germany
Unknown Facility
Regensburg, 93049, Germany
Unknown Facility
Napoli, Campania, 80131, Italy
Unknown Facility
Bologna, Emilia-Romagna, 40138, Italy
Unknown Facility
Udine, Friuli Venezia Giulia, 33100, Italy
Unknown Facility
Milan, Lombardy, 20132, Italy
Unknown Facility
Milan, Lombardy, 20141, Italy
Unknown Facility
Milan, Lombardy, 20162, Italy
Unknown Facility
Pavia, Lombardy, 27100, Italy
Unknown Facility
Olsztyn, 10-228, Poland
Unknown Facility
Szczecin, 70-111, Poland
Unknown Facility
Sabadell, Barcelona, Barcelona, 08208, Spain
Unknown Facility
Santander, Cantabria, 39008, Spain
Unknown Facility
Barcelona, 08035, Spain
Unknown Facility
Barcelona, 08036, Spain
Unknown Facility
Barcelona, 08907, Spain
Unknown Facility
Madrid, 28007, Spain
Unknown Facility
Madrid, 28050, Spain
Unknown Facility
Seville, 41013, Spain
Unknown Facility
Valencia, 46010, Spain
Unknown Facility
Aberdeen, AB25 2ZN, United Kingdom
Unknown Facility
Belfast, BT9 7AB, United Kingdom
Unknown Facility
Bournemouth, BH7 7DW, United Kingdom
Unknown Facility
Cardiff, CF14 2TL, United Kingdom
Unknown Facility
Dorchester, DT1 2JY, United Kingdom
Unknown Facility
Glasgow, G12 0YN, United Kingdom
Unknown Facility
London, SE1 9RT, United Kingdom
Unknown Facility
London, SW3 6JJ, United Kingdom
Unknown Facility
London, WC1E 6DD, United Kingdom
Unknown Facility
Northwood, HA6 2RN, United Kingdom
Unknown Facility
Romford, RM7 0AG, United Kingdom
Unknown Facility
Weston-super-Mare, BS23 4TQ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2011
First Posted
March 30, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
November 17, 2022
Record last verified: 2022-11