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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Beijing Northland Biotech. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01663441
First received: August 9, 2012
Last updated: March 23, 2015
Last verified: March 2015
  Purpose
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.

Condition Intervention Phase
Chemotherapy-induced Thrombocytopenia
Drug: NL201
Drug: rhIL-11
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Multicenter, Randomized Phase Ⅲ Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy.

Resource links provided by NLM:


Further study details as provided by Beijing Northland Biotech. Co., Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nadir platelet counts [ Time Frame: During 21 days of chemotherapy cycles ] [ Designated as safety issue: No ]
  • Platelet counts at day 21 after the initiation of chemotherapy. [ Time Frame: Day 21 after the initiation of chemotherapy. ] [ Designated as safety issue: No ]
  • Average platelet counts [ Time Frame: During 21 days of chemotherapy cycles ] [ Designated as safety issue: No ]
  • Incidence of thrombocytopenia [ Time Frame: During 21 days of chemotherapy cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1

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.

Drug: NL201
mIL-11:5μg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy;
Other Name: mIL-11
Drug: NL201
mIL-11:7.5μg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy;
Other Name: mIL-11
Experimental: A2

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.

Drug: NL201
mIL-11:5μg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy;
Other Name: mIL-11
Drug: NL201
mIL-11:7.5μg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy;
Other Name: mIL-11
Active Comparator: A

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.

Drug: NL201
The optimal dosing dose NL201,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
Other Name: mIL-11
Drug: rhIL-11
rhIL-11(25μg/kg),subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
Other Name: Recombinant Human Interleukin-11 for Injection
Active Comparator: B

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.

Drug: NL201
The optimal dosing dose NL201,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
Other Name: mIL-11
Drug: rhIL-11
rhIL-11(25μg/kg),subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
Other Name: Recombinant Human Interleukin-11 for Injection

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663441

Locations
China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China
China, Heilongjiang
The Third Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China
Sponsors and Collaborators
Beijing Northland Biotech. Co., Ltd.
  More Information

Responsible Party: Beijing Northland Biotech. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01663441     History of Changes
Other Study ID Numbers: NL201-Ⅲ-2012 
Study First Received: August 9, 2012
Last Updated: March 23, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Northland Biotech. Co., Ltd.:
Chemotherapy
Thrombocytopenia
Interleukin-11
Platelet

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Oprelvekin
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 25, 2016