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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chemotherapy-induced Thrombocytopenia

In brief

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.

Key facts

Study ID

NCT03471078

Run by

Sobi, Inc.

People needed

122

Starts

2018-10-12

Expected to finish

2023-01-31

Last updated by the study team

2023-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dova Site — Bakersfield, California, United States
• Dova Site — Riverside, California, United States
• Dova Site — Santa Monica, California, United States
• Dova Site — Augusta, Georgia, United States
• Dova Site — Harvey, Illinois, United States
• Dova Site — Skokie, Illinois, United States
• Dova Site — Bloomington, Indiana, United States
• Dova Site — Wichita, Kansas, United States
• Dova Site — Ashland, Kentucky, United States
• Dova Site — Boston, Massachusetts, United States
• Dova Site — Minneapolis, Minnesota, United States
• Dova Site — Canton, Ohio, United States
• Dova Site — Gettysburg, Pennsylvania, United States
• Dova Site — Harbin, China
• Dova Site — Linyi, China
• Dova Site — Neijiang, China
• Dova Site — Shanghai, China
• Dova Site — Tianjin, China
• Dova Site — Budapest, Hungary
• Dova Site — Debrecen, Hungary
• Dova Site — Nyíregyháza, Hungary
• Dova Site — Törökbálint, Hungary
• Dova Site — Lublin, Poland
• Dova Site — Olsztyn, Poland
• Dova Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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