Colorectal Cancer Clinical Trial

Eisai 7820

INDICATION:
Metastatic Colorectal Cancer

TITLE:
An Open-Label, Multicenter, Randomized Phase 2 Study of FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer

IRB NAME:
Copernicus IRB

STATUS:
Expected to open May 2010

PHASE:
2

PURPOSES:

• To evaluate the safety and tolerability of E7820 administered in combination with the FOLFIRI regimen in patients with locally advanced or metastatic colorectal cancer who have failed first-line therapy
• To preliminarily assess the efficacy of E7820 administered in combination with the FOLFIRI regimen in patients with locally advanced or metastatic colorectal cancer who have failed first-line therapy

ELIGIBILITY:
Candidates must:

• Be male or female aged 18 years or older
• Have histologically or cytologically confirmed nonresectable locally advanced or metastatic colorectal adenocarcinoma
• Have at least 1 site of measurable disease
• No chemotherapy within 30 days before start of study treatment

DURATION:
Screening and baseline; 1 visit per cycle until disease progression.

CONTACT/ADDITIONAL INFO:
Isabella Rodrigues, PhD
Clinical Research Coordinator
908-277-8630