Multicenter, Randomized Phase Ⅲ Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy
18 Years
75 Years
Both
Chemotherapy-induced Thrombocytopenia
Trial Information
Multicenter, Randomized Phase Ⅲ Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy
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 efficacy and safety of low-dose mIL-11 on CIT patients receiving
suitable chemotherapeutic regimen for treating cancer.
Inclusion Criteria:
- histological verification of malignancy at the time of initial diagnosis；
- Patients (age,18-75 years) receiving chemotherapy, who had experienced platelet
counts below 75×109/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
>3.0×109/L,platelet count ≥100×109/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.
Exclusion Criteria:；
- patients who received total body irradiation；
- patients with childbearing potential；
- patients who were breast-feeding or pregnant
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Outcome Measure:
Comparison of average platelet counts between mIL-11 and rhIL-11 at day 21 after the initiation of chemotherapy
Outcome Time Frame:
day 21 after the initiation of chemotherapy
Safety Issue:
No
Authority:
China: Food and Drug Administration
Study ID:
NL201-Ⅲ-2012
NCT ID:
NCT01663441
Start Date:
August 2012
Completion Date:
Related Keywords:
- Chemotherapy-Induced Thrombocytopenia
- Chemotherapy
- Thrombocytopenia
- Interleukin-11
- Platelet
- Thrombocytopenia
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