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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01326000




Registration number
NCT01326000
Ethics application status
Date submitted
29/03/2011
Date registered
30/03/2011
Date last updated
6/02/2015

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
BP25438
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FOLFIRI
Treatment: Drugs - RO5083945
Treatment: Drugs - cetuximab

Experimental: KRAS WT A -

Active Comparator: KRAS WT B -

Experimental: KRAS mutant A -

Active Comparator: KRAS mutant B -


Treatment: Drugs: FOLFIRI
standard iv chemotherapy

Treatment: Drugs: RO5083945
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter

Treatment: Drugs: cetuximab
400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
Timepoint [1] 0 0
approximately 18 months
Secondary outcome [1] 0 0
Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria
Timepoint [1] 0 0
approximately 18 months
Secondary outcome [2] 0 0
Duration of response: time from complete or partial response to disease progression or death
Timepoint [2] 0 0
approximately 18 months
Secondary outcome [3] 0 0
Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria
Timepoint [3] 0 0
approximately 18 months
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0
approximately 18 months
Secondary outcome [5] 0 0
Safety: Incidence of adverse events
Timepoint [5] 0 0
approximately 18 months
Secondary outcome [6] 0 0
Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa
Timepoint [6] 0 0
approximately 18 months

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- Newcastle
Recruitment hospital [2] 0 0
- Port Macquarie
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Box Hill
Recruitment hospital [5] 0 0
- East Bentleigh
Recruitment hospital [6] 0 0
- Frankston
Recruitment postcode(s) [1] 0 0
2298 - Newcastle
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
5041 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
VIC 3165 - East Bentleigh
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
Belgium
State/province [7] 0 0
Bruxelles
Country [8] 0 0
Belgium
State/province [8] 0 0
Edegem
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
France
State/province [11] 0 0
Bordeaux
Country [12] 0 0
France
State/province [12] 0 0
Brest
Country [13] 0 0
France
State/province [13] 0 0
Lille
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
Saint Herblain
Country [16] 0 0
France
State/province [16] 0 0
Toulouse
Country [17] 0 0
Germany
State/province [17] 0 0
Essen
Country [18] 0 0
Germany
State/province [18] 0 0
Hamburg
Country [19] 0 0
Germany
State/province [19] 0 0
Hannover
Country [20] 0 0
Germany
State/province [20] 0 0
Heidelberg
Country [21] 0 0
Germany
State/province [21] 0 0
Herne
Country [22] 0 0
Germany
State/province [22] 0 0
Regensburg
Country [23] 0 0
Italy
State/province [23] 0 0
Campania
Country [24] 0 0
Italy
State/province [24] 0 0
Emilia-Romagna
Country [25] 0 0
Italy
State/province [25] 0 0
Friuli-Venezia Giulia
Country [26] 0 0
Italy
State/province [26] 0 0
Lombardia
Country [27] 0 0
Poland
State/province [27] 0 0
Olsztyn
Country [28] 0 0
Poland
State/province [28] 0 0
Szczecin
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Cantabria
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Sevilla
Country [33] 0 0
Spain
State/province [33] 0 0
Valencia
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Aberdeen
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Belfast
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Bournemouth
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Cardiff
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Dorchester
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Glasgow
Country [40] 0 0
United Kingdom
State/province [40] 0 0
London
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Northwood
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Romford
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Weston Super Mare

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01326000
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications