Overview

This trial is active, not recruiting.

Condition chemotherapy-induced thrombocytopenia
Treatments nl201, rhil-11
Phase phase 3
Sponsor Beijing Northland Biotech. Co., Ltd.
Start date March 2015
End date August 2017
Trial size 300 participants
Trial identifier NCT01663441, NL201-Ⅲ-2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
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.
nl201 mIL-11
mIL-11:5μg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy;
nl201 mIL-11
mIL-11:7.5μg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy;
(Experimental)
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.
nl201 mIL-11
mIL-11:5μg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy;
nl201 mIL-11
mIL-11:7.5μg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy;
(Active Comparator)
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.
nl201 mIL-11
The optimal dosing dose NL201,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
rhil-11 Recombinant Human Interleukin-11 for Injection
rhIL-11(25μg/kg),subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
(Active Comparator)
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.
nl201 mIL-11
The optimal dosing dose NL201,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
rhil-11 Recombinant Human Interleukin-11 for Injection
rhIL-11(25μg/kg),subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Multicenter, Randomized Phase Ⅲ Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Beijing Northland Biotech. Co., Ltd..