Bladder Cancer Clinical Trial
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
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.
Full 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.
Eligibility 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
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There are 16 Locations for this study
Anaheim California, 92801, United States
Bakersfield California, 93309, United States
Riverside California, 92501, United States
Santa Monica California, 90403, United States
Augusta Georgia, 30912, United States
Harvey Illinois, 60426, United States
Skokie Illinois, 60076, United States
Bloomington Indiana, 47403, United States
Wichita Kansas, 67214, United States
Ashland Kentucky, 41101, United States
Boston Massachusetts, 02114, United States
Minneapolis Minnesota, 55417, United States
Canton Ohio, 44718, United States
Gettysburg Pennsylvania, 17325, United States
Harbin , , China
Linyi , , China
Neijiang , , China
Shanghai , , China
Tianjin , , China
Budapest , , Hungary
Debrecen , , Hungary
Nyiregyhaza , , Hungary
Törökbálint , , Hungary
Lublin , , Poland
Olsztyn , , Poland
Prabuty , , Poland
Tomaszów Mazowiecki , , Poland
Warsaw , , Poland
Arkhangel'sk , , Russian Federation
Kazan , , Russian Federation
Kursk , , Russian Federation
Moscow , , Russian Federation
Novosibirsk , , Russian Federation
Omsk , , Russian Federation
Pyatigorsk , 35750, Russian Federation
Saint Petersburg , 18866, Russian Federation
Saint Petersburg , , Russian Federation
Saransk , , Russian Federation
Sochi , , Russian Federation
Belgrade , , Serbia
Kragujevac , , Serbia
Sremska Kamenica , , Serbia
Cherkasy , , Ukraine
Chernihiv , , Ukraine
Chernivtsi , , Ukraine
Ivano-Frankivs'k , , Ukraine
Kharkiv , , Ukraine
Kherson , , Ukraine
Kropyvnytskyi , , Ukraine
Kyiv , , Ukraine
Odesa , , Ukraine
Sumy , , Ukraine
Ternopil' , , Ukraine
Uzhhorod , , Ukraine
Vinnytsia , , Ukraine
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