Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Hetrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of solid tumors and lymphomas.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• Men and women, 18-75 years of age;

• Participant with a confirmed diagnosis of solid tumor or lymphoma by histopathological or cytological examination receiving a chemotherapy regimen given in a 21 or 28-day cycle, including 1 or more of the following agents or class of agents: Antimetabolie Antineoplastic agents including gemcitabine, Antitumor Platinum drugs including Carboplatin or cisplatin, Anthracycline Alkylating agent, Alkylating agent or other chemotherapy which could induce thrombocytopenia;

• Participant experienced moderate thrombocytopenia, defined as two platelet counts within 30×109-75×109/L measured at least 24 h apart, during the previous chemotherapy cycle;

• In the previous day before dosing of Hemtrombopag (Day -1), subjects has a platelet count within 100×109-200×109/L, neutrophil count≥1.5×109/L, haemoglobin≥90g/L;

• Subject has a life expectancy≥12 weeks at screening and is able to receive at least two additional cycles of the current chemotherapy regimen when screening;

• ECOG performance status 0-1;

• Subjects of childbearing potential must agree to use a highly effective method of contraception, except subjects with surgically sterile;

• Subject is willing to participate in the study, and Subject must provide written informed consent.

Exclusion Criteria:

• Subject has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of Screening;

• Subject has any history of hematologic diseases other than lymphoma and CIT;

• Solid tumor with invasion of bone marrow;

• Subject has received radiotherapy;

• Subject has a history of arterial or venous thrombosis within 6 months of Screening;

• Subject has a history of significant cardiovascular disease (eg, congestive heart failure New York Heart Association Grade 3/4, arrhythmia known to increase the risk of thromboembolic events (eg, atrial fibrillation), coronary artery stent placement, angioplasty, or coronary artery bypass graft;

• Subject has previously received a thrombopoietin receptor agonist (eg, eltrombopag), rhTPO or rhIL11 for the treatment of CIT;