A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients… (NCT07286032) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
United States150 participantsStarted 2026-04-16
Plain-language summary
The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
✓. Life expectancy ≥6 months.
✓. Signed ICF for voluntary participation in the study and good compliance.
Exclusion criteria
✕. 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.
✕. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
✕. Severe cardiovascular disorders or interventions within 6 months
What they're measuring
1
Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.
Timeframe: around 6 months.
2
Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months
Timeframe: around 6 months
3
Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months
Timeframe: around 6 months
4
Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years
Timeframe: around 3 years
5
Part B:No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until Cycle 2 Day 21, around 3 years.
Timeframe: around 3 years.
6
Part B:Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years;