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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

approximately 18 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BP25438

NCT ID:

NCT01326000

Start Date:

April 2011

Completion Date:

August 2013

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Philadelphia, Pennsylvania  19104
Omaha, Nebraska  68114
Charlotte, North Carolina  
Charleston, South Carolina