A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Interventions
- Registration Number
- NCT01663441
- Lead Sponsor
- Beijing Northland Biotech. Co., Ltd.
- Brief Summary
This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.
- Detailed Description
The investigators recently developed a mutant form of rhIL-11 with improved stability. In in vitro experimental systems, mIL-11 was shown to endure chemical and proteolytic stresses more effectively, while retaining the biological activity of the original rhIL-11. The improved stability of mIL-11 was also demonstrated in the comparative pharmacokinetic study of subcutaneously delivered mIL-11 and rhIL-11 in the rodent and primate models. Based on its improved pharmacokinetic and pharmacodynamic features. In Phase II study shows that mIL-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT. This study is a phase III, single-blinded, randomized,multicenter,cross-over study designed to evaluate optimal dosing dose and efficacy and safety of mIL-11 on CIT patients receiving suitable chemotherapeutic regimen for treating cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- histological verification of malignancy at the time of initial diagnosis；
- Patients (age,18-75 years) receiving chemotherapy, who had experienced platelet counts below 75×10^9/L；
- patients were required to have adequate bone marrow,hepatic, and renal functions at the time of study entry；
- ECOG ≤2；
- patients to have normal laboratory findings:while white blood count >3.0×10^9/L,platelet count ≥100×10^9/L, and AST and/or ALT lesser than 2.5 times the upper limit of the normal value；
- The estimated life expectancy of the patient was more than 3 months.
；
- patients who received total body irradiation；
- patients with childbearing potential；
- patients who were breast-feeding or pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A rhIL-11 Patients in this treatment group will receive NL201（optimal dosing dose）in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive rhIL-11(25μg/kg). Only in Phase Ⅲb. A NL201 Patients in this treatment group will receive NL201（optimal dosing dose）in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive rhIL-11(25μg/kg). Only in Phase Ⅲb. B rhIL-11 Patients in this treatment group will receive rhIL-11(25μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201（optimal dosing dose）. Only in Phase Ⅲb. A2 NL201 Patients in this treatment group will receive NL201(7.5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(5μg/kg). Only for Dose-finding in Phase Ⅲa. B NL201 Patients in this treatment group will receive rhIL-11(25μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201（optimal dosing dose）. Only in Phase Ⅲb. A1 NL201 Patients in this treatment group will receive NL201(5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(7.5μg/kg). Only for Dose-finding in Phase Ⅲa.
- Primary Outcome Measures
Name Time Method Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L. During 21 days of chemotherapy cycles
- Secondary Outcome Measures
Name Time Method Platelet counts at day 21 after the initiation of chemotherapy. Day 21 after the initiation of chemotherapy. Average platelet counts During 21 days of chemotherapy cycles Nadir platelet counts During 21 days of chemotherapy cycles Incidence of thrombocytopenia During 21 days of chemotherapy cycles
Trial Locations
- Locations (5)
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
The Third Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China