Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.

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

Details

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

Criteria

Inclusion Criteria:

1. Men and women, 18-75 years of age;

2. Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents;

3. Participant experienced thrombocytopenia and chemotherapy delay;

4. ECOG performance status 0-1;

5. Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x ULN for participants without liver metastases or 5.0 x ULN for participant with liver metastases);

6. Adequate renal function; serum creatinine < 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault）

Exclusion Criteria:

1. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;

2. Participant has serious bleeding symptoms;

3. History of allergy to the study drug;

4. Participant with HIV;

5. Pregnant or lactating women;

6. Participant has received any experimental therapy within 4 weeks prior to screening

7. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion