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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Northland Biotech. Co., Ltd.
• Treatments: Oprelvekin

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