Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
NCT ID: NCT03471078
Last Updated: 2023-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
122 participants
INTERVENTIONAL
2018-10-12
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Avatrombopag
Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.
Avatrombopag
Oral avatrombopag tablet
Placebo
Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.
Placebo Oral Tablet
Placebo comparator tablet
Interventions
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Avatrombopag
Oral avatrombopag tablet
Placebo Oral Tablet
Placebo comparator tablet
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Sobi, Inc.
INDUSTRY
Responsible Party
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Locations
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Dova Site
Anaheim, California, United States
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
Prabuty, , Poland
Dova Site
Tomaszów Mazowiecki, , Poland
Dova Site
Warsaw, , Poland
Dova Site
Arkhangelsk, , Russia
Dova Site
Kazan', , Russia
Dova Site
Kursk, , Russia
Dova Site
Moscow, , Russia
Dova Site
Novosibirsk, , Russia
Dova Site
Omsk, , Russia
Dova Site
Pyatigorsk, , Russia
Dova Site
Saint Petersburg, , Russia
Dova Site
Saint Petersburg, , Russia
Dova Site
Saransk, , Russia
Dova Site
Sochi, , Russia
Dova Site
Belgrade, , Serbia
Dova Site
Kamenitz, , Serbia
Dova Site
Kragujevac, , Serbia
Dova Site
Cherkasy, , Ukraine
Dova Site
Chernihiv, , Ukraine
Dova Site
Chernivtsi, , Ukraine
Dova Site
Ivano-Frankivsk, , Ukraine
Dova Site
Kharkiv, , Ukraine
Dova Site
Kherson, , Ukraine
Dova Site
Kropyvnytskyi, , Ukraine
Dova Site
Kyiv, , Ukraine
Dova Site
Odesa, , Ukraine
Dova Site
Sumy, , Ukraine
Dova Site
Ternopil, , Ukraine
Dova Site
Uzhhorod, , Ukraine
Dova Site
Vinnytsia, , Ukraine
Countries
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References
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Al-Samkari H, Kolb-Sielecki J, Safina SZ, Xue X, Jamieson BD. Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2022 Mar;9(3):e179-e189. doi: 10.1016/S2352-3026(22)00001-1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AVA-CIT-330
Identifier Type: -
Identifier Source: org_study_id
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