Colorectal CancerPhase 2NCT01326000
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 Phase 2 study testing FOLFIRI, RO5083945 and cetuximab in people with Colorectal Cancer, run by Hoffmann-La Roche at 69 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FOLFIRI, RO5083945 and cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 69 sitesin 9 countries
- Study dates
- Apr 2011to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
69 sites in 9 countries.
69 sites in 9 countries
United States16 sites
Study site
Charlotte, North Carolina, 28204
Study site
Durham, North Carolina, 27710
Study site
Encinitas, California, 92024
Study site
Greenville, South Carolina, 29615
Study site
Harvey, Illinois, 60426
Study site
Highland, California, 92346
Study site
La Jolla, California, 92037
Study site
La Verne, California, 91750
Study site
Los Angeles, California, 90033
Study site
Los Angeles, California, 90095
Study site
Memphis, Tennessee, 38119
Study site
San Diego, California, 92123
Study site
Sayre, Pennsylvania, 18840
Study site
Skokie, Illinois, 60076
Study site
Skokie, Illinois, 60077
Study site
Winston-Salem, North Carolina, 27103
United Kingdom12 sites
Study site
Aberdeen, AB25 2ZN
Study site
Belfast, BT9 7AB
Study site
Bournemouth, BH7 7DW
Study site
Cardiff, CF14 2TL
Study site
Dorchester, DT1 2JY
Study site
Glasgow, G12 0YN
Study site
London, SE1 9RT
Study site
London, SW3 6JJ
Study site
London, WC1E 6DD
Study site
Northwood, HA6 2RN
Study site
Romford, RM7 0AG
Study site
Weston-super-Mare, BS23 4TQ
Spain9 sites
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Barcelona, 08907
Study site
Madrid, 28007
Study site
Madrid, 28050
Study site
Sabadell, Barcelona, Barcelona, 08208
Study site
Santander, Cantabria, 39008
Study site
Seville, 41013
Study site
Valencia, 46010
Italy7 sites
Study site
Bologna, Emilia-Romagna, 40138
Study site
Milan, Lombardy, 20132
Study site
Milan, Lombardy, 20141
Study site
Milan, Lombardy, 20162
Study site
Naples, Campania, 80131
Study site
Pavia, Lombardy, 27100
Study site
Udine, Friuli Venezia Giulia, 33100
Australia6 sites
Study site
Adelaide, South Australia, 5041
Study site
Box Hill, Victoria, 3128
Study site
EAST Bentleigh, Victoria, VIC 3165
Study site
Frankston, Victoria, 3199
Study site
Newcastle, New South Wales, 2298
Study site
Port Macquarie, New South Wales, 2444
France6 sites
Study site
Bordeaux, 33075
Study site
Brest, 29200
Study site
Lille, 59037
Study site
Paris, 75679
Study site
Saint-Herblain, 44805
Study site
Toulouse, 31059
Germany6 sites
Study site
Essen, 45122
Study site
Hamburg, 20246
Study site
Hanover, 30625
Study site
Heidelberg, 69120
Study site
Herne, 44625
Study site
Regensburg, 93049
Belgium5 sites
Study site
Brussels, 1000
Study site
Brussels, 1200
Study site
Edegem, 2650
Study site
Ghent, 9000
Study site
Leuven, 3000
About this study
Official title: 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
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.
- Conditions
- Colorectal Cancer
- Being tested
- FOLFIRI, RO5083945, cetuximab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRIDrug
standard iv chemotherapy
RO5083945Drug
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
cetuximabDrug
400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
| Study group | Role | What they receive |
|---|---|---|
| KRAS WT A | Experimental | Not described Receives: Drug: FOLFIRI; Drug: RO5083945 |
| KRAS WT B | Active comparator | Not described Receives: Drug: FOLFIRI; Drug: cetuximab |
| KRAS mutant A | Experimental | Not described Receives: Drug: FOLFIRI; Drug: RO5083945 |
| KRAS mutant B | Active comparator | Not described Receives: Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
Measured: approximately 18 months
Secondary outcomes (6)
Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria
Measured: approximately 18 months
Duration of response: time from complete or partial response to disease progression or death
Measured: 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
Measured: approximately 18 months
Overall survival
Measured: approximately 18 months
Safety: Incidence of adverse events
Measured: approximately 18 months
Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa
Measured: approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326000
- Sponsor's protocol ID
- BP25438
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2011
- Last updated
- 17 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01326000
- Acronym / sponsor ID
- BP25438
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KRAS WT A | Experimental | Drug: FOLFIRI, Drug: RO5083945 |
| KRAS WT B | Active comparator | Drug: FOLFIRI, Drug: cetuximab |
| KRAS mutant A | Experimental | Drug: FOLFIRI, Drug: RO5083945 |
| KRAS mutant B | Active comparator | Drug: FOLFIRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFIRIstandard iv chemotherapy | Drug | KRAS WT A, KRAS WT B, KRAS mutant A, KRAS mutant B |
| RO50839451400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter | Drug | KRAS WT A, KRAS mutant A |
| cetuximab400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week | Drug | KRAS WT B |
Primary outcome
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
Time frame: approximately 18 months
6 secondary outcomes
Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria
Time frame: approximately 18 months
Duration of response: time from complete or partial response to disease progression or death
Time frame: 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
Time frame: approximately 18 months
Overall survival
Time frame: approximately 18 months
Safety: Incidence of adverse events
Time frame: approximately 18 months
Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa
Time frame: approximately 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
69 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFIRI, RO5083945 and cetuximab in people with Colorectal Cancer, run by Hoffmann-La Roche at 69 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, United Kingdom, Spain, Italy, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria (time frame: approximately 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.