Cancer Treatment-Induced Thrombocytopenia
Conditions
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.
Interventions
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of treatment responders. | Randomization up to 80 days |
Secondary
| Measure | Time frame |
|---|---|
| Duration from the commencement of treatment to a platelet count ≥100×109/L | Randomization up to 30 days |
| 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 |
Countries
China
Contacts
CONTACTJun Ma
CONTACTShukui Qin
Outcome results
None listed