The ExCIT study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
Male or female, age ≥ 18 years at screening.
Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 14- or 21-day treatment cycles.
Platelet count < 85 x 109/L at enrollment.
WHO Grade ≥ 2 bleeding within 14 days prior to screening.
Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
Hematologic malignancies.
Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
Sequential
Hetrombopag Olamine
DrugFor Part A, all participants would receive hetrombopag treatment.
Hetrombopag Olamine; Hetrombopag Olamine Placebo
DrugFor Part B, participants would be randomized to receive hetrombopag treatment or matching placebo, respectively.
Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.
Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months.
Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months.
Part B: A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years.
Proportion of participants achieving platelet count ≥100×109/L without the use of rescue therapy within 14 days after initiating the investigational product treatment, around 3 years.
Platelet count nadir from Cycle 1 Day 1 until the primary treatment period, around 3 years.
Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until the primary treatment period, around 3 years.
Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until the primary treatment period, around 3 years.
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