Recruiting NCT07286032
A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hetrombopag Olamine, Hetrombopag Olamine ；Hetrombopag Olamine Placebo.
- Who it may be relevant to
- Registry conditions: Patients With Chemotherapy-Induced Thrombocytopenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug Hetrombopag Olamine
For Part A, all participants would receive hetrombopag treatment. - Drug Hetrombopag Olamine ；Hetrombopag Olamine Placebo
For Part B，participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。
Primary outcome measures
- Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months. [Time frame: around 6 months.]
- Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months [Time frame: around 6 months]
- Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months [Time frame: around 6 months]
- Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years [Time frame: 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. [Time frame: 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; [Time frame: around 3 years;]
Secondary outcome measures (5)
- 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; [Time frame: around 3 years;]
- platelet count nadir from Cycle 1 Day 1 until Cycle 2 Day 21, around 3 years; [Time frame: 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; [Time frame: 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. [Time frame: around 3 years.]
- Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years. [Time frame: around 3 years.]
Eligibility criteria
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).
- Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
- 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
- Have arterial/venous thrombosis within 6 months
- Known bleeding disorders, platelet dysfunction
- Severe haemorrhage during screening
- Acute or uncontrolled hepatitis B\&C infection
- Human immunodeficiency virus (HIV) infection.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Cancer and Blood Specialty Clinic — Los Alamitos
- AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology — Denver
- Oncology & Hematology Associates of West Broward — Coral Springs
- Mid-Florida Hematology & Oncology Centers, P.A. — Orange City
- Springfield Clinic — Springfield
- Morristown Medical Center — Morristown
- New York Cancer and Blood Specialists One Oncology — Shirley
Identifiers
NCT: NCT07286032 · SHR8735-303