Status:
COMPLETED
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
Lead Sponsor:
Sobi, Inc.
Conditions:
Chemotherapy-induced Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 tre...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03471078
Start Date
October 12 2018
End Date
January 31 2023
Last Update
September 28 2023
Active Locations (55)
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1
Dova Site
Anaheim, California, United States, 92801
2
Dova Site
Bakersfield, California, United States, 93309
3
Dova Site
Riverside, California, United States, 92501
4
Dova Site
Santa Monica, California, United States, 90403