Patients With Chemotherapy-Induced Thrombocytopenia
Conditions
Brief 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.
Interventions
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。
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 than CIT (e.g., primary immune thrombocytopenia). 2. Hematologic malignancies. 3. 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. 4. Untreated brain metastases; or with leptomeningeal metastasis. 5. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression). 6. Severe cardiovascular disorders or interventions within 6 months 7. Have arterial/venous thrombosis within 6 months 8. Known bleeding disorders, platelet dysfunction 9. Severe haemorrhage during screening 10. Acute or uncontrolled hepatitis B\&C infection 11. Human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months. | around 6 months. |
| Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months | around 6 months |
| Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months | around 6 months |
| Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years | around 3 years |
| 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. | around 3 years. |
| 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; | around 3 years; |
Secondary
| Measure | Time frame |
|---|---|
| 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; | around 3 years; |
| platelet count nadir from Cycle 1 Day 1 until Cycle 2 Day 21, around 3 years; | 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; | 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. | around 3 years. |
| Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years. | around 3 years. |
Countries
United States
Contacts
CONTACTJunye Xiong
Outcome results
None listed