A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
Jiangsu HengRui Medicine Co., Ltd.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female gender, age ≥18 years at screening. 2. Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma \[NSCLC\], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer). 3. Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2. 5. Life expectancy ≥6 months. 6. Signed ICF for voluntary participation in the study and good compliance. Exclusion Criteria: 1. Hematopoietic diseases other…
Interventions
- DrugHetrombopag Olamine
For Part A, all participants would receive hetrombopag treatment.
- DrugHetrombopag Olamine ；Hetrombopag Olamine Placebo
For Part B，participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。
Locations (7)
- Cancer and Blood Specialty ClinicLos Alamitos, California
- AdventHealth Hematology and Oncology Denver Cypress Hematology and OncologyDenver, Colorado
- Oncology & Hematology Associates of West BrowardCoral Springs, Florida
- Mid-Florida Hematology & Oncology Centers, P.A.Orange City, Florida
- Springfield ClinicSpringfield, Illinois
- Morristown Medical CenterMorristown, New Jersey