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
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|ClinicalTrials.gov Identifier: NCT05261646|
Recruitment Status : Not yet recruiting
First Posted : March 2, 2022
Last Update Posted : March 2, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-Induced Thrombocytopenia||Drug: Hetrombopag Drug: Matching placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||183 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Stage 1： Hetrombopag lower dose； Hetrombopag higher dose
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）
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female gender, age ≥18 years.
- Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Expected survival ≥ 6 months at screening.
- At least 2 remaining chemotherapy cycles with current chemotherapy regimen.
- 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.
- Signed ICF for voluntary participation in the study and good compliance.
- PC <25×109/L or ≥75 x 109/L at screening or enrollment.
- 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 before screening.
- Intracranial metastases or disease.
- Bone marrow involvement or bone marrow metastasis on routine imaging.
- Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
- Pelvic, spinal radiotherapy, or large-field bone radiation received within 3 months prior to screening.
- 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.
- 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.
- Known bleeding disorders, platelet dysfunction.
- 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.
- Severe hemorrhage (e.g., gastrointestinal, or intracranial hemorrhage) within 2 weeks before screening.
- 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.
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.
- Abnormal renal function: estimated glomerular filtration rate (eGFR) ≤ 60 mL/min (Cockcroft-Gault estimated creatinine clearance).
- Previous treatments with TPO-R agonists (e.g., eltrombopag, romiplostim) at any time before screening or enrollment.
- Platelet transfusion received within 72 hours prior to screening or enrollment, with PC >75×109/L at screening or enrollment.
- Known or expected allergy or intolerance to the active substances or excipients of hetrombopag.
- Acute or chronic hepatitis C or hepatitis B.
- Human immunodeficiency virus (HIV) infection.
- 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).
- Pregnancy/intention to become pregnant during the study period or lactation.
- Participation in another clinical trial within 30 days or 5 half-lives of an investigational product (whichever is longer) prior to screening.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT05261646
|Contact: Sergey Zaets, MD, PhDemail@example.com|
|Contact: Karina Kardenas, MD, PhD||+1-571-216-0982||Karina.firstname.lastname@example.org|
|Responsible Party:||Jiangsu HengRui Medicine Co., Ltd.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Blood Platelet Disorders