A Study With Tasquinimod Treating Patients With Hepatocellular, Ovarian, Renal Cell and Gastric Cancers

Phase 2 Completed 201 enrolled Ipsen

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This was an exploratory proof of concept study to determine the clinical activity of tasquinimod in patients with advanced or metastatic hepatocellular carcinoma, ovarian carcinoma, renal cell carcinoma and gastric carcinoma who had progressed after standard therapies.

Timeline

Start: 2012-12
Primary completion: 2014-12
Completion: 2016-04

Outcome

Missed primary endpoint

paper The pre-defined PFS threshold was not reached in the hepatocellular cancer cohort at the second stage of the trial. PMID 28798986 ↗

paper This study failed to demonstrate clinical activity of tasquinimod in heavily pre-treated patients with advanced hepatocellular, ovarian, renal cell, and gastric cancer. PMID 28798986 ↗

Publications

Escudier B, Faivre S, Van Cutsem E, Germann N, Pouget JC, Plummer R, Vergote I, Thistlethwaite F, Bjarnason GA, Jones R, Mackay H, Edeline J, Fartoux L, Hirte H, Oza A. A Phase II Multicentre, Open-Label, Proof-of-Concept Study of Tasquinimod in Hepatocellular, Ovarian, Renal Cell, and Gastric Cancers. Target Oncol. 2017 Oct;12(5):655-661. doi: 10.1007/s11523-017-0525-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tasquinimod	Small molecule	0.25 mg	Oral
Subject	Tasquinimod	Small molecule	0.5 mg	Oral
Subject	Tasquinimod	Small molecule	1 mg	Oral