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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | 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. |
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| A2 | 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. |
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| A | 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. |
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| B | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NL201 | Drug | mIL-11:5μg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy; |
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| Measure | Description | Time Frame |
|---|---|---|
| Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L. | During 21 days of chemotherapy cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Nadir platelet counts | During 21 days of chemotherapy cycles | |
| Platelet counts at day 21 after the initiation of chemotherapy. | Day 21 after the initiation of chemotherapy. | |
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Inclusion Criteria:
Exclusion Criteria:;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | China | |||
| The Third Affiliated Hospital of Harbin Medical University |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C105308 | oprelvekin |
| D017370 | Interleukin-11 |
| D007267 | Injections |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| NL201 | Drug | mIL-11:7.5μg/kg,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy; |
|
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| NL201 | Drug | The optimal dosing dose NL201,subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy. |
|
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| rhIL-11 | Drug | rhIL-11(25μg/kg),subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy. |
|
|
| Average platelet counts |
| During 21 days of chemotherapy cycles |
| Incidence of thrombocytopenia | During 21 days of chemotherapy cycles |
| Harbin |
| Heilongjiang |
| China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | China |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |