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

Chemotherapy-Induced Thrombocytopenia Clinical Trial

Official title:

Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-induced Thrombocytopenia in Adults With Solid Tumors.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05864014
• Other study ID #: SHR8735-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2023
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Qian Tang
• Phone: +86 177 2128 6353
• Email: Qian.tang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 192
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-Induced Thrombocytopenia
• Thrombocytopenia

Intervention

Drug:
• Hetrombopag
Hetrombopag
• Hetrombopag plus Placebo
Hetrombopag plus Placebo
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of treatment responders.		Randomization up to 80 days
Secondary	Duration from the commencement of treatment to a platelet count =100×109/L;		Randomization up to 30 days
Secondary	Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and;		Randomization up to 160 days
Secondary	Proportion of subjects without serious bleeding events;		Randomization up to 190 days
Secondary	Number of adverse events (AEs)/serious adverse events (SAEs)		Randomization up to 190 days