Trial intelligence / Profile preview

Surufatinib vs Capecitabine in Advanced Biliary Tract Carcinoma

NCT03873532Phase 3

Key facts

Status: Unknown
Start: Jul 2018
Primary completion: Jun 2021
Countries: 1
Sponsor: Hutchison MediPharma (HMP)
Modality: Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands

Drugs: surufatinib
Conditions: biliary tract cancer (BTC)

Overview

Phase 3, randomised, open-label trial of surufatinib in biliary tract cancer (BTC) (2 arms), sponsored by Hutchison MediPharma (HMP). Primary endpoint: Overall Survival. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Active Group (Surufatinib)
Surufatinib 300 mg QD
Control Group (Capecitabine)
Capecitabine 1250 mg/m2 BID (2w on/1w off)

Who it enrols

Adult patients with unresectable or metastatic biliary tract cancer who have failed first-line gemcitabine + platinum chemotherapy.

Endpoints

Primary

Overall Survival5 months after the last patient enrolled

Secondary

Progression-Free Survival5 months after the last patient enrolled
Objective Remission Rate5 months after the last patient enrolled
Disease Control Rate5 months after the last patient enrolled
Duration of Response5 months after the last patient enrolled

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