search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FOLFIRI
RO5083945
cetuximab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

KRAS WT A

KRAS WT B

KRAS mutant A

KRAS mutant B

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria

Secondary Outcome Measures

Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria
Duration of response: time from complete or partial response to disease progression or death
Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria
Overall survival
Safety: Incidence of adverse events
Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa

Full Information

First Posted
March 29, 2011
Last Updated
November 16, 2022
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT01326000
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KRAS WT A
Arm Type
Experimental
Arm Title
KRAS WT B
Arm Type
Active Comparator
Arm Title
KRAS mutant A
Arm Type
Experimental
Arm Title
KRAS mutant B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
standard iv chemotherapy
Intervention Type
Drug
Intervention Name(s)
RO5083945
Intervention Description
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
Primary Outcome Measure Information:
Title
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
Time Frame
approximately 18 months
Secondary Outcome Measure Information:
Title
Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria
Time Frame
approximately 18 months
Title
Duration of response: time from complete or partial response to disease progression or death
Time Frame
approximately 18 months
Title
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
Title
Overall survival
Time Frame
approximately 18 months
Title
Safety: Incidence of adverse events
Time Frame
approximately 18 months
Title
Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa
Time Frame
approximately 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
City
Highland
State/Province
California
ZIP/Postal Code
92346
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
City
EAST Bentleigh
State/Province
Victoria
ZIP/Postal Code
VIC 3165
Country
Australia
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Bordeaux
ZIP/Postal Code
33075
Country
France
City
Brest
ZIP/Postal Code
29200
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Paris
ZIP/Postal Code
75679
Country
France
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Herne
ZIP/Postal Code
44625
Country
Germany
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Sabadell, Barcelona
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28050
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
City
Dorchester
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
City
London
ZIP/Postal Code
WC1E 6DD
Country
United Kingdom
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
City
Weston Super Mare
ZIP/Postal Code
BS23 4TQ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs