Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers

Phase 3 Completed 122 enrolled Sobi, Inc.

RandomizedParallel-groupDouble-blindSupportive care

Summary

Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder cancer.

Timeline

Start: 2018-10-12
Primary completion: 2020-08-28
Completion: 2023-01-31

Outcome

Missed primary endpoint

registry analysis (other test); Avatrombopag vs Placebo; p = 0.7186; Mean Difference (Final Values) -3.0 (95% CI -21.7 to 15.6); Cochran-Mantel-Haenszel NCT03471078 ↗

release “While we are disappointed that avatrombopag failed to show efficacy in CIT” sobi.com ↗

release “the study did not meet the composite primary endpoint” sobi.com ↗

Publications

Background Al-Samkari H, Kolb-Sielecki J, Safina SZ, Xue X, Jamieson BD. Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2022 Mar;9(3):e179-e189. doi: 10.1016/S2352-3026(22)00001-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avatrombopag	Small molecule	—	Oral