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.

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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.

View Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

122

Study ID:

NCT03471078

Recruitment Status:

Completed

Sponsor:

Sobi, Inc.

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There are 16 Locations for this study

See Locations Near You

Dova Site
Anaheim California, 92801, United States
Dova Site
Bakersfield California, 93309, United States
Dova Site
Riverside California, 92501, United States
Dova Site
Santa Monica California, 90403, United States
Dova Site
Augusta Georgia, 30912, United States
Dova Site
Harvey Illinois, 60426, United States
Dova Site
Skokie Illinois, 60076, United States
Dova Site
Bloomington Indiana, 47403, United States
Dova Site
Wichita Kansas, 67214, United States
Dova Site
Ashland Kentucky, 41101, United States
Dova Site
Boston Massachusetts, 02114, United States
Dova Site
Minneapolis Minnesota, 55417, United States
Dova Site
Canton Ohio, 44718, United States
Dova Site
Gettysburg Pennsylvania, 17325, United States
Dova Site
Harbin , , China
Dova Site
Linyi , , China
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Neijiang , , China
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Shanghai , , China
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Tianjin , , China
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Budapest , , Hungary
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Debrecen , , Hungary
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Nyiregyhaza , , Hungary
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Törökbálint , , Hungary
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Lublin , , Poland
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Olsztyn , , Poland
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Prabuty , , Poland
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Tomaszów Mazowiecki , , Poland
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Warsaw , , Poland
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Arkhangel'sk , , Russian Federation
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Kazan , , Russian Federation
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Kursk , , Russian Federation
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Moscow , , Russian Federation
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Novosibirsk , , Russian Federation
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Omsk , , Russian Federation
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Pyatigorsk , 35750, Russian Federation
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Saint Petersburg , 18866, Russian Federation
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Saint Petersburg , , Russian Federation
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Saransk , , Russian Federation
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Sochi , , Russian Federation
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Belgrade , , Serbia
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Kragujevac , , Serbia
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Sremska Kamenica , , Serbia
Dova Site
Cherkasy , , Ukraine
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Chernihiv , , Ukraine
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Chernivtsi , , Ukraine
Dova Site
Ivano-Frankivs'k , , Ukraine
Dova Site
Kharkiv , , Ukraine
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Kherson , , Ukraine
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Kropyvnytskyi , , Ukraine
Dova Site
Kyiv , , Ukraine
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Odesa , , Ukraine
Dova Site
Sumy , , Ukraine
Dova Site
Ternopil' , , Ukraine
Dova Site
Uzhhorod , , Ukraine
Dova Site
Vinnytsia , , Ukraine

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

122

Study ID:

NCT03471078

Recruitment Status:

Completed

Sponsor:


Sobi, Inc.

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