Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sobi, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
