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QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia

RecruitingPhase 2, Phase 3

Sponsor: Qilu Pharmaceutical Co., Ltd.

Conditions: Cancer Treatment-Induced Thrombocytopenia

Interventions: QL0911, QL0911 plus Placebo, Placebo

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

Harbin, China
Nanjing, China