Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)

Phase 3 Completed 666 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients \>= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy

Timeline

Start: 2013-01-29
Primary completion: 2014-08-12
Completion: 2021-05-28

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo + Low-dose Cytarabine vs Volasertib + Low-dose Cytarabine; p = 0.0024; Odds Ratio (OR) 1.8751 (95% CI 1.2432 to 2.8281) NCT01721876 ↗

Publications

Hagege A, Ambrosetti D, Boyer J, Bozec A, Doyen J, Chamorey E, He X, Bourget I, Rousset J, Saada E, Rastoin O, Parola J, Luciano F, Cao Y, Pages G, Dufies M. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy. Theranostics. 2021 Sep 21;11(19):9571-9586. doi: 10.7150/thno.61711. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Volasertib	Small molecule	—	Intravenous
Background	Cytarabine	Small molecule	—	Subcutaneous