Clinical trial NCT01663441: A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11
Official title: Multicenter, Randomized Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-induced Thrombocytopenia
Keywords: Chemotherapy
Thrombocytopenia
Interleukin-11
Platelet
Lead sponsor: Beijing Northland Biotech. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L.
timeFrame: During 21 days of chemotherapy cycles
Secondary outcomes:
measure: Nadir platelet counts
timeFrame: During 21 days of chemotherapy cycles
measure: Platelet counts at day 21 after the initiation of chemotherapy.
timeFrame: Day 21 after the initiation of chemotherapy.
measure: Average platelet counts
timeFrame: During 21 days of chemotherapy cycles
measure: Incidence of thrombocytopenia
timeFrame: During 21 days of chemotherapy cycles
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Harbin
country: China
facility: The Third Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: