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A Clinical Study of Hetrombopag Olamine Tablets in Adults Receiving 21-day Cycles of Chemotherapy for Solid Tumours, Who Are Delayed for at Least 1 Week From Their Scheduled Cycle Because of Chemotherapy-induced Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05261646
Recruitment Status : Not yet recruiting
First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
The study is aimed to evaluate the efficacy of different doses of hetrombopag compared to placebo, measured by the proportion of subjects that can complete two planned consecutive chemotherapy cycles with no modification of chemotherapy regimen (i.e., delayed start, dose reduction, omission, or discontinuation) because of thrombocytopenia [platelet count <100×109/L], to determine an optimal dose of hetrombopag and to demonstrate its superiority over placebo.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Thrombocytopenia Drug: Hetrombopag Drug: Matching placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Stage Phase Ⅲ Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets in Treatment of Chemotherapy-Induced Thrombocytopenia
Estimated Study Start Date : April 15, 2022
Estimated Primary Completion Date : March 15, 2025
Estimated Study Completion Date : December 15, 2025

Arm Intervention/treatment
Experimental: Hetrombopag Drug: Hetrombopag

Stage 1: Hetrombopag lower dose; Hetrombopag higher dose

Stage 2:

Hetrombopag X mg (dose to be determined based on Stage 1 results)

Placebo Comparator: Matching placebo Drug: Matching placebo
Matching placebo(Stage 1;Stage 2)

Primary Outcome Measures :
  1. Proportion of treatment "responders" who do not require modification of chemotherapy regimen because of thrombocytopenia (PC <100×109/L) during two planned consecutive chemotherapy cycles without the use of rescue treatment. [ Time Frame: 56 days after the first dose of study drug ]
    Cochran-Mantel-Haenszel (CMH) test will be used to make a comparison between each hetrombopag group and the placebo group.

Secondary Outcome Measures :
  1. Time to first platelet response, defined by PC ≥100×109/L. [ Time Frame: 56 days after the first dose of study drug ]

    Will be analyzed by a log-rank test stratified by the randomization stratification factors.

    The Kaplan-Meier (KM) method will be used to describe the time-to-event data.

  2. Proportion of subjects achieving PC ≥100×109/L. [ Time Frame: 14 days after the first dose of study drug ]
    Will be analyzed with the CMH test

  3. Time duration of PC ≥100×109/L. [ Time Frame: 42 days after the start of the first chemotherapy cycle ]
    Will be analyzed with the log rank test and KM plots

  4. PC nadir from the start of the first on-study chemotherapy cycle through the end of the double-blind treatment period. [ Time Frame: 42 days after the start of the first chemotherapy cycle] ]
    An Analysis of Covariance (ANCOVA) will be used.

  5. Time duration of severe thrombocytopenia, defined as a PC of 50×109/L [ Time Frame: 56 days after the first dose of study drug ]
    Will be analyzed with the log rank test and KM plots.

  6. Proportion of subjects without serious bleeding events, defined as grade ≥ 2, according to the World Health Organization Bleeding scale. [ Time Frame: 56 days after the first dose of study drug ]
    Will be analyzed with the CMH test.

  7. Proportion of subjects with at least single incidence of platelet transfusion or other rescue treatment. [ Time Frame: 56 days after the first dose of study drug ]
    Will be analyzed with the CMH test.

  8. Proportion of patients without chemotherapy regimen modifications due to any cause. [ Time Frame: 14 days after the first dose of study drug ]
    Will be analyzed with the CMH test.

  9. Number adverse events (AEs) as assessed by CTCAE v5.0. [ Time Frame: up to 140 days of treatment with study drug plus 6 months of follow-up. ]
    Arithmetic summary statistics will be provided.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female gender, age ≥18 years.
  2. Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
  3. Receiving a chemotherapy cycle of 21 days with one or more of the following chemotherapeutic drugs:

    • Antimetabolites, including gemcitabine, etc.
    • Platinum-based agents, including carboplatin, nedaplatin, cisplatin, and lobaplatin, etc.
    • Anthracyclines, including doxorubicin, daunorubicin, epirubicin, etc.
    • Alkylating agents, including cyclophosphamide, ifosfamide, etc.
  4. Delay for at least 1 week from the scheduled chemotherapy cycle because of thrombocytopenia (PC <75×109/L for 4 weeks after the start of the previous chemotherapy cycle.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  6. Expected survival ≥ 6 months at screening.
  7. At least 2 remaining chemotherapy cycles with current chemotherapy regimen.
  8. Agreement for subjects of childbearing potential to take effective contraceptive measures throughout the study (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive diaphragm, contraceptive cream, contraceptive suppository, abstinence, and inserted intrauterine devices, etc.); except female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation or have been in menopause for more than 1 year, and male subjects who have undergone bilateral vasectomy or ligation.
  9. Signed ICF for voluntary participation in the study and good compliance.

Exclusion Criteria:

  1. PC <25×109/L or ≥75 x 109/L at screening or enrollment.
  2. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
  3. Hematologic malignancies.
  4. Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months before screening.
  5. Intracranial metastases or disease.
  6. Bone marrow involvement or bone marrow metastasis on routine imaging.
  7. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
  8. Pelvic, spinal radiotherapy, or large-field bone radiation received within 3 months prior to screening.
  9. Severe cardiovascular disorders or interventions within 6 months before screening: New York Heart Association (NYHA) Class III-IV; arrhythmias known to increase the risk of thromboembolism (e.g., atrial fibrillation); prolonged QTc (>450 msec for males and >460 msec for females); coronary artery angioplasty, stenting, or bypass grafting.
  10. Any arterial or venous thrombosis (e.g., deep vein thrombosis, pulmonary embolism, transient ischemic attack/stroke, or myocardial infarction) within 6 months prior to screening.
  11. Known bleeding disorders, platelet dysfunction.
  12. Use of anticoagulants or non-steroidal anti-inflammatory drugs (NSAIDs) within 7 days of screening. The use of low dose aspirin (81 mg) is allowed.
  13. Severe hemorrhage (e.g., gastrointestinal, or intracranial hemorrhage) within 2 weeks before screening.
  14. Absolute neutrophil count (ANC) <1.5× 109/L, or Hb <80 g/L. Use of granulocyte colony stimulating factor, red blood cell, or erythropoietin infusion therapy that meets routine clinical practice is allowed.
  15. Significantly abnormal liver function:

    • For subjects without liver metastasis: alanine aminotransferase/aspartate aminotransferase (ALT/AST) > 3 × ULN (upper limit of normal), TBL > 3 × ULN.
    • For subjects with liver metastases: ALT/AST ≥ 5 × ULN, TBL > 3 × ULN.
  16. Abnormal renal function: estimated glomerular filtration rate (eGFR) ≤ 60 mL/min (Cockcroft-Gault estimated creatinine clearance).
  17. Previous treatments with TPO-R agonists (e.g., eltrombopag, romiplostim) at any time before screening or enrollment.
  18. Platelet transfusion received within 72 hours prior to screening or enrollment, with PC >75×109/L at screening or enrollment.
  19. Known or expected allergy or intolerance to the active substances or excipients of hetrombopag.
  20. Acute or chronic hepatitis C or hepatitis B.
  21. Human immunodeficiency virus (HIV) infection.
  22. Confirmed SARS-CoV-2 (COVID-19) infection (validated test positive), or suspected COVID-19 infection (clinical symptoms without documented test results) within 4 weeks before screening, or close contact with a person with known or suspected COVID-19 infection within 2 weeks before screening (subject may be included with a documented negative result for a validated COVID-19 test).
  23. Pregnancy/intention to become pregnant during the study period or lactation.
  24. Participation in another clinical trial within 30 days or 5 half-lives of an investigational product (whichever is longer) prior to screening.
  25. Investigator's judgement that participation in the study creates a significant risk for the health of a subject, or his/her condition may affect evaluation of the safety and/or efficacy of hetrombopag.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05261646

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Contact: Sergey Zaets, MD, PhD +1-609-384-1879
Contact: Karina Kardenas, MD, PhD +1-571-216-0982

Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd. Identifier: NCT05261646    
Other Study ID Numbers: HR-TPO-CIT-301
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Blood Platelet Disorders
Hematologic Diseases