A Proof of Concept Study of Maintenance Therapy With Tasquinimod in Patients With Metastatic Castrate-resistant Prostate Cancer Who Are Not Progressing After a First Line Docetaxel Based Chemotherapy

Summary

The purpose of this study is to confirm that tasquinimod used as maintenance therapy is active and tolerable in patients with metastatic castrate-resistant prostate cancer not progressing after a first chemotherapy with docetaxel.

Timeline

Start

2013-01

Primary completion

2015-02

Completion

2015-05

Outcome

Met primary endpoint

Stopped: “Development of tasquinimod in prostate cancer discontinued”

registry analysis (unspecified test); Tasquinimod vs Placebo; p =0.0315; Log Rank NCT01732549 ↗

paper Maintenance tasquinimod therapy significantly reduced the risk of rPFS by 40%. PMID 29059273 ↗

Publications

• Fizazi K, Ulys A, Sengelov L, Moe M, Ladoire S, Thiery-Vuillemin A, Flechon A, Guida A, Bellmunt J, Climent MA, Chowdhury S, Dumez H, Matouskova M, Penel N, Liutkauskiene S, Stachurski L, Sternberg CN, Baton F, Germann N, Daugaard G. A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy. Ann Oncol. 2017 Nov 1;28(11):2741-2746. doi: 10.1093/annonc/mdx487.

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

Indications