Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors

NCT04609891 | Completed

• 1 other identifier: SKXCIT001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

To observe the clinical efficacy and safety of avatrombopag for chemotherapy-induced thrombocytopenia in patients with malignant tumors.

Conditions

Thrombocytopenia

Keywords

chemotherapy; rh-TPO; avatrombopag

Outcome Measures

Primary Outcomes (1)

• Proportion of responders

  Proportion of patients with platelet count ≥100×10\^9/L or increase of platelet count ≥50×10\^9/L or ≥100% from baseline within cycle X after initiation of avatrombopag treatment.Due to chemotherapy induced thrombocytopenia in the X+1 cycle, the dose reduction in chemotherapy of X+2 cycle by ≥15% or chemotherapy delay by ≥4 days.

  up to 2 months

Secondary Outcomes (5)

• Duration of grade Ⅲ and Ⅳ thrombocytopenia after initiation of avatrombopag treatment

  up to 2 months

• Time for PLT to recover to ≥75×10^9/L and ≥100×10^9/L after initiation of avatrombopag treatment

  up to 2 months

• minimal platelet count

  up to 2 months

• Proportion of patients without platelet transfusion

  up to 2 months

• Proportion of patients without bleeding

  up to 2 months

Study Arms (1)

Avatrombopag Tablets Oral

EXPERIMENTAL

When patient is diagnosed with thrombocytopenia induced by chemotherapy of malignant tumor, avatrombopag will be given to patients as a therapeutic plan.

Drug: Avatrombopag

Interventions

Avatrombopag DRUG

10×109/L\<PLT\<75×109/L, avatrombopag tablet 60 mg once a day for 5-10 days.

Avatrombopag Tablets Oral

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18\~75 years.
• Diagnosed with malignant tumors (gynecological tumors, gastrointestinal tumors, lung cancer, gastric cancer and head and neck tumors) by pathology or cytology and need chemotherapy.
• The subject had developed at least grade II thrombocytopenia after the last chemotherapy cycle (10×109/L\<PLT count\<75×109/L).
• Subjects' Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
• The subjects' life expectancy at the time of screening is ≥12 weeks, and must continue to receive at least 2 cycles of the same chemotherapy regimen at the time of screening.
• Women of childbearing age must have taken reliable contraceptive measures, or have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial.
• The subjects voluntarily and strictly abide by the requirements of the research protocol and sign a written informed consent.

You may not qualify if:

• Subjects suffer from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; according to NYHA standards, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination suggests left ventricular ejection fraction ( LVEF) \<50%.
• Subjects have clinically significant acute or active bleeding (such as gastrointestinal or central nervous system) within 7 days before screening.
• Subjects received major surgery or minor surgery within 4 weeks of enrollment ≤ 3 days.
• Subjects had a history of arterial or venous thrombosis (such as myocardial ischemia, transient ischemic attack, or stroke) within 6 months before screening.
• Subjects had active infection or acute infection occurred within 2 weeks before the first administration of the study.
• Long-term bed rest, subjects with severe vascular disease.
• Subjects had a history of chronic thrombocytopenia or bleeding disorders, or a history of thrombocytopenia (such as chronic liver disease or immune thrombocytopenic purpura) caused by causes other than thrombocytopenia caused by chemotherapy.
• Subjects had a history of other malignant tumors, such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid malignant tumor, myelodysplastic syndrome, myeloproliferative disease, and multiple myeloma.
• There are factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction.
• Subjects had an allergic reaction to avatrombopag or any of its excipients.
• Subjects participated in clinical studies of other study drugs or devices within 30 days before screening.
• The investigator assessed that the subjects had any accompanying medical history that could impair the subject's safety in completing the study, such as renal failure due to hemodialysis or active infection requiring intravenous antibiotics.
• Subjects had a history of psychotropic drug abuse and unable to quit or have mental disorders.
• Pregnant or breastfeeding women, and fertile patients who are unwilling or unable to take effective contraceptive measures.
• The investigator judges other conditions that may affect the conduct of clinical research and the determination of research results.

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead

Study Sites (1)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230000, China

Location

Related Publications (1)

• Cui Y, He Y, Hu C, Tu C, Huang J, Zhu X, Zang C, Ding K, Zhan B, Zhao Y, Qian L. Avatrombopag for the treatment of thrombocytopenia induced by chemotherapy in patients with solid tumors: A multicenter, open-label, single-arm trial. Front Pharmacol. 2022 Sep 27;13:970978. doi: 10.3389/fphar.2022.970978. eCollection 2022.

  PMID: 36238568 DERIVED

MeSH Terms

Conditions

Thrombocytopenia

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 30, 2020
• Study Start: May 26, 2020
• Primary Completion: May 16, 2021
• Study Completion: May 16, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

CN (1)