A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11

Beijing Northland Biotech. Co., Ltd.62 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Chemotherapy-induced Thrombocytopenia

Interventions

NL201DRUG

mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；

NL201DRUG

mIL-11:7.5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；

NL201DRUG

The optimal dosing dose NL201，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 75×10\^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. Exclusion Criteria:； * patients who received total body irradiation； * patients with childbearing potential； * patients who were breast-feeding or pregnant

Locations (5)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The Third Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Hospital of Jilin University

Changchun, Jilin, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L.

Time frame: During 21 days of chemotherapy cycles

Secondary Outcomes

Nadir platelet counts

Time frame: During 21 days of chemotherapy cycles

Platelet counts at day 21 after the initiation of chemotherapy.

Time frame: Day 21 after the initiation of chemotherapy.

Average platelet counts

Time frame: During 21 days of chemotherapy cycles

Incidence of thrombocytopenia

Time frame: During 21 days of chemotherapy cycles

Data from ClinicalTrials.gov

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