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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01326000
Ethics application status
Date submitted
29/03/2011
Date registered
30/03/2011
Date last updated
17/11/2022

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
Sex
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
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
169
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01326000