Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.

QL0911-302

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.

2024-07-01

2026-07-01

2026-12-01

Not yet recruiting

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 235, 'type': 'ESTIMATED'}}

2024-06-13