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

NCT05261646 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: HR-TPO-CIT-301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chemotherapy-Induced Thrombocytopenia

Outcome Measures

Primary Outcomes (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.

  Cochran-Mantel-Haenszel (CMH) test will be used to make a comparison between each hetrombopag group and the placebo group.

  56 days after the first dose of study drug

Secondary Outcomes (9)

• Time to first platelet response, defined by PC ≥100×109/L.

  56 days after the first dose of study drug

• Proportion of subjects achieving PC ≥100×109/L.

  14 days after the first dose of study drug

• Time duration of PC ≥100×109/L.

  42 days after the start of the first chemotherapy cycle

• PC nadir from the start of the first on-study chemotherapy cycle through the end of the double-blind treatment period.

  42 days after the start of the first chemotherapy cycle]

• Time duration of severe thrombocytopenia, defined as a PC of 50×109/L

  56 days after the first dose of study drug

Study Arms (2)

Hetrombopag

EXPERIMENTAL

Drug: Hetrombopag

Matching placebo

PLACEBO COMPARATOR

Drug: Matching placebo

Interventions

Hetrombopag DRUG

Stage 1： Hetrombopag lower dose； Hetrombopag higher dose Stage 2: Hetrombopag X mg (dose to be determined based on Stage 1 results)

Hetrombopag

Matching placebo DRUG

Matching placebo（Stage 1；Stage 2）

Matching placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Interventions

hetrombopag

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: April 15, 2022
• Primary Completion: March 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 28, 2023

Record last verified: 2022-02