QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia

Phase 2

Not yet recruiting

• Conditions: Cancer Treatment-Induced Thrombocytopenia
• Interventions: Drug: QL0911; Drug: QL0911 plus Placebo; Drug: Placebo

• Registration Number: NCT06456528
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Study Start: 2024-07
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

• Men and women, 18-75 years of age;
• Histopathological or cytological examination confirmed cancer , chemotherapy cycle of 21 days;
• Participant experienced thrombocytopenia and chemotherapy delay;
• ECOG performance status 0-1;
• The estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles.

Exclusion Criteria

• Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
• Participant has serious bleeding symptoms;
• History of allergy to the study drug;
• Patients with hepatitis C antibody positive and detection of HCV-RNA exceeding the upper limit, patients with hepatitis B surface antigen positive and detection of HBV-DNA exceeding the upper limit, patients with severe cirrhosis, HIV antibody positive and syphilis antibody positive;
• Pregnant or lactating women;
• Participant has received any experimental therapy within 28 days prior to screening
• Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QL0911	QL0911	-
QL0911 plus Placebo	QL0911 plus Placebo	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The proportion of treatment responders.	Randomization up to 80 days

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy	Randomization up to 150 days
Number of adverse events (AEs)/serious adverse events (SAEs)	Randomization up to 150 days
Duration from the commencement of treatment to a platelet count ≥100×109/L	Randomization up to 30 days