Clinical Trial Protocol Registry

Trial information

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

Status:
Active, not recruiting
Protocol number:
BP25438
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official 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
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. Target sample size is 169.
Study phase:
II
Study type:
Interventional; Treatment; Non-randomized; Parallel; Safety/efficacy study
Conditions:
  • Colorectal Cancer
Intervention type:
Drug
Intervention name:
RO5083945
Primary outcome:
  1. Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria Time frame: approximately 18 months
Key secondary outcomes:
  1. Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria Time frame: approximately 18 months
  2. Duration of response: time from complete or partial response to disease progression or death Time frame: approximately 18 months
  3. 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
  4. Overall survival Time frame: approximately 18 months
  5. Safety: Incidence of adverse events Time frame: approximately 18 months
  6. Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa Time frame: approximately 18 months
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
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
April, 2011
Trial registration date:
19.10.2010
Date last updated:
06.05.2013
This trial was conducted at the following locations:
Australia
  • ADELAIDE
  • EAST BENTLEIGH
  • MELBOURNE
  • NEWCASTLE
  • PORT MACQUARIE
AUSTRALIA
  • Frankston, Victo
Belgium
  • BRUXELLES
  • EDEGEM
  • GENT
  • LEUVEN
France
  • BORDEAUX
  • PARIS
  • SAINT HERBLAIN
  • TOULOUSE
Germany
  • HAMBURG
  • HEIDELBERG
  • REGENSBURG
GERMANY
  • Hannover
Italy
  • MILANO
  • NAPOLI
  • PAVIA
  • UDINE
ITALY
  • MILANO
Poland
  • OLSZTYN
  • SZCZECIN
Spain
  • BARCELONA
  • MADRID
  • SABADELL
  • SANTANDER
  • SEVILLA
  • VALENCIA
SPAIN
  • Barcelona, BARCE
U.S.A.
  • ENCINITAS, CA
  • LA JOLLA, CA
  • LA VERNE, CA
  • LOS ANGELES, CA
  • SAN DIEGO, CA
  • SANTA MONICA, CA
  • DURHAM, NC
  • WINSTON-SALEM, NC
  • GRAND ISLAND, NE
  • SAYRE, PA
  • GREENVILLE, SC
United Kingdom
  • ABERDEEN
  • BELFAST
  • GLASGOW
  • LONDON
  • ROMFORD
  • WESTON SUPER MARE
UNITED KINGDOM
  • CARDIFF
  • LONDON
UNITED STATES
  • Harvey, IL

Link to trial result

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