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

Chemotherapy-induced Thrombocytopenia Clinical Trial

Official title:

Multicenter, Randomized Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663441
• Other study ID #: NL201-?-2012
• Status: Completed
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: August 2017

Study information

• Verified date: July 2017
• Source: Beijing Northland Biotech. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Thrombocytopenia
• Thrombocytopenia

Intervention

Drug:
• NL201
mIL-11:5µg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy;
• NL201
mIL-11:7.5µg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy;
• NL201
The optimal dosing dose NL201,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
• rhIL-11
rhIL-11(25µg/kg),subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Third Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Northland Biotech. Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nadir platelet counts		During 21 days of chemotherapy cycles
Secondary	Platelet counts at day 21 after the initiation of chemotherapy.		Day 21 after the initiation of chemotherapy.
Secondary	Average platelet counts		During 21 days of chemotherapy cycles
Secondary	Incidence of thrombocytopenia		During 21 days of chemotherapy cycles

External Links

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