Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non… (NCT03471078) | Clinical Trial Compass
CompletedPhase 3
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
United States122 participantsStarted 2018-10-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 m…
What they're measuring
1
Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days