Trial intelligence / Profile preview

CS-7017 in Metastatic Colorectal Cancer After First-Line Chemotherapy

NCT00986440Phase 2

Key facts

Status: Terminated
Start: Jul 2009
Primary completion: Oct 2012
Countries: 9
Sponsor: Daiichi Sankyo Co., Ltd.
Modality: Orthosteric Ligands

Drugs: efatutazone
Conditions: colorectal cancer (CRC)

Overview

Phase 2, randomised, double-blind trial in colorectal cancer (CRC) comparing CS-7017 with Placebo (2 arms). Primary endpoint: Percentage Rate of Progression-free Survival at 18 weeks. Started Jul 2009; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

CS-7017
Efatutazone monotherapy
Placebo
Placebo matching CS-7017

Who it enrols

Patients with metastatic CRC who achieved disease control after 1st line chemotherapy, excluding those with diabetes requiring treatment or brain metastases.

Endpoints

Primary

Percentage Rate of Progression-free Survival18 weeks

Secondary

Percentage Rate of Progression-free Survival30 weeks
Percentage Rate of Overall Survival12 months
Best Overall Responseup to 3 years 3 months
Objective Response Rateup to 3 years 3 months
Duration of Responseup to 3 years 3 months
Number of Participants With Treatment-Emergent Adverse Eventsup to 3 years 3 months

Results

Primary endpoints met

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