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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01326000
First received: March 29, 2011
Last updated: August 19, 2014
Last verified: August 2014

March 29, 2011
August 19, 2014
April 2011
December 2013   (final data collection date for primary outcome measure)
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01326000 on ClinicalTrials.gov Archive Site
  • Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
  • Duration of response: time from complete or partial response to disease progression or death [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
  • Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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 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 effi cacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuxi mab or FOLFIRI alone as second line treatment in patients with metastatic colore ctal cancer. Patients will be randomized to receive RO5083945 (1400 mg intraveno usly on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv c hemotherapy 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: RO5083945
    1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
  • Drug: FOLFIRI
    standard iv chemotherapy
  • Drug: cetuximab
    400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
  • Experimental: KRAS WT A
    Interventions:
    • Drug: RO5083945
    • Drug: FOLFIRI
  • Active Comparator: KRAS WT B
    Interventions:
    • Drug: FOLFIRI
    • Drug: cetuximab
  • Experimental: KRAS mutant A
    Interventions:
    • Drug: RO5083945
    • Drug: FOLFIRI
  • Active Comparator: KRAS mutant B
    Intervention: Drug: FOLFIRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
169
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   France,   Germany,   Italy,   Poland,   Spain,   United Kingdom
 
NCT01326000
BP25438
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP