A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia

Официальное название

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

Обзор

The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.

Вмешательства

• Препарат Hetrombopag Olamine
  For Part A, all participants would receive hetrombopag treatment.
• Препарат Hetrombopag Olamine ；Hetrombopag Olamine Placebo
  For Part B，participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。

Первичные конечные точки

• Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months. [Срок оценки: around 6 months.]
• Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months [Срок оценки: around 6 months]
• Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months [Срок оценки: around 6 months]
• Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years [Срок оценки: 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. [Срок оценки: 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; [Срок оценки: around 3 years;]

Вторичные конечные точки (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; [Срок оценки: around 3 years;]
• platelet count nadir from Cycle 1 Day 1 until Cycle 2 Day 21, around 3 years; [Срок оценки: 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; [Срок оценки: 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. [Срок оценки: around 3 years.]
• Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years. [Срок оценки: around 3 years.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 7 центров

• 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

Идентификаторы

NCT: NCT07286032 · SHR8735-303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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