RecruitingPhase 2Phase 3NCT06456528
QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.
Sponsor
Qilu Pharmaceutical Co., Ltd.
Enrollment
235 participants
Start Date
Oct 22, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- 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 Criteria7
- 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
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Interventions
DRUGQL0911
QL0911
DRUGQL0911 plus Placebo
QL0911 plus Placebo
DRUGPlacebo
Placebo
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06456528