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

This study is not yet open for participant recruitment.
Verified July 2012 by Beijing Northland Biotech. Co., Ltd.
Sponsor:
Collaborators:
Peking University Third Hospital
Beijing Cancer Hospital
Beijing Chao Yang Hospital
Beijing Friendship Hospital
Beijing Chest Hospital
Tianjin Medical University Cancer Institute and Hospital
China Medical University, China
First Hospital of Jilin University
The Third Affiliated Hospital of Harbin Medical University
The First Affiliated Hospital of Soochow University
Information provided by (Responsible Party):
Beijing Northland Biotech. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01663441
First received: August 9, 2012
Last updated: August 10, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of genetically modified recombinant human IL- 11 (mIL-11), using original IL-11 as an active control, in a multicenter randomized trial.


Condition Intervention Phase
Chemotherapy-induced Thrombocytopenia
 Drug: mIL-11
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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:

MedlinePlus related topics: Cancer
Drug Information available for: Oprelvekin
U.S. FDA Resources

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

Primary Outcome Measures:
  • Comparison of average platelet counts between mIL-11 and rhIL-11 at day 21 after the initiation of chemotherapy [ Time Frame: day 21 after the initiation of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recovery time of platelet counts from nadir to normal level [ Time Frame: 21days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Comparison of average nadir platelet counts between mIL-11 and rhIL-11 during chemotherapy cycles [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 380
Study Start Date: August 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IL-11
mIL11: 7.5 μg/kg rhIL-11: 25μg/kg
 Drug: mIL-11
mIL-11:7.5μg/kg ，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy； rhIL-11:25μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after 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 efficacy and safety of low-dose mIL-11 on CIT patients receiving suitable chemotherapeutic regimen for treating cancer.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
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 75×109/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 >3.0×109/L,platelet count ≥100×109/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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663441

Locations
China, Beijing
Beijing Northland Biotech. Co., Ltd. Not yet recruiting
Beijing, Beijing, China, 100085
Contact: Shanshan Ma, Master     86-10-82890893 ext 19     mashanshan@northland-bio.com    
Principal Investigator: Shikai Wu, Doctor            
Sponsors and Collaborators
Beijing Northland Biotech. Co., Ltd.
Peking University Third Hospital
Beijing Cancer Hospital
Beijing Chao Yang Hospital
Beijing Friendship Hospital
Beijing Chest Hospital
Tianjin Medical University Cancer Institute and Hospital
China Medical University, China
First Hospital of Jilin University
The Third Affiliated Hospital of Harbin Medical University
The First Affiliated Hospital of Soochow University
  More Information

No publications provided

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: August 10, 2012
Health Authority: China: Food and Drug Administration
China: Ethics Committee

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013