NCT03471078

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

Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Sobi, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects will receive placebo controlled test treatment for one cycle of chemotherapy followed by an observational cycle. Subjects will have the option to continue into an open label extension period for all remaining chemotherapy cycles within the current regimen. After the follow-up visit, all subjects will continue to a long-term safety follow-up period.

Conditions

• Chemotherapy-induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Avatrombopag	Oral avatrombopag tablet
DRUG	Placebo Oral Tablet	Placebo comparator tablet

Timeline

• Start date: 2018-10-12
• Primary completion: 2020-08-28
• Completion: 2023-01-31
• First posted: 2018-03-20
• Last updated: 2023-09-28
• Results posted: 2021-11-24

Locations

55 sites across 7 countries: United States, China, Hungary, Poland, Russia, Serbia, Ukraine

Regulatory

• FDA-regulated drug study