The 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 gender, 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 21-day treatment cycles.
Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
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.
Untreated brain metastases; or with leptomeningeal metastasis.
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 Cycle 2 Day 21, around 3 years;
Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until C2D21, around 3 years;
Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until Cycle 2 Day 21, around 3 years.
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