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

• Status: Active, not recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dova Pharmaceuticals

Criteria

Inclusion Criteria:

• Men and women greater than or equal to 18 years of age;

• A diagnosis of ovarian, lung (small cell or non-small cell) or bladder cancer requiring systemic chemotherapy

• Participant receiving a chemotherapy regimen given in a 21 or 28-day cycle, including 1 or more of the following agents or class of agents:

• Nucleoside analog, including gemcitabine and fluorouracil;

• Carboplatin or cisplatin;

• Anthracycline; or

• Alkylating agent;

• Participant experienced severe thrombocytopenia, defined as 2 platelet counts <50 x 109/L measured at least 24 hours apart, during the qualifying chemotherapy cycle, of their current chemotherapy regimen

• ECOG performance status <=2

Exclusion Criteria:

• Participant has experienced >=Grade 2 CIT other than during the current chemotherapy treatment regimen within 6 months of Screening;

• Participant has any history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases;

• Participant has received >2 previous lines of chemotherapy or is receiving whole brain radiation during the study treatment period;

• Participant has a known medical history of genetic prothrombotic syndromes

• Participant has a history of arterial or venous thrombosis within 3 months of screening;

• Use of vitamin K antagonists;

• Participant has previously received a thrombopoietin receptor agonist or recombinant human thrombopoietin for the treatment of CIT within 3 months of screening