Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

Summary

Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who achieved an objective response of Disease Control on first line therapy with Folinic acid (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.

Timeline

Start

2009-07-31

Primary completion

2012-10-29

Completion

2012-10-29

Outcome

Met primary endpoint

Stopped: “Due to changes to the standard of care within the proposed market for CS-7017.”

registry analysis (superiority test); CS-7017 0.5 mg vs Placebo; p <0.0001; Z statistic for difference 3.92; 2-sided P value for z test NCT00986440 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	efatutazone	Small molecule	—	—

Indications