NCT01663441

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
2.5 years until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 16, 2020

Status Verified

July 1, 2017

Enrollment Period

2.4 years

First QC Date

August 9, 2012

Last Update Submit

September 14, 2020

Conditions

Chemotherapy-induced Thrombocytopenia

Keywords

ChemotherapyThrombocytopeniaInterleukin-11Platelet

Outcome Measures

Primary Outcomes (1)

  • Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L.

    During 21 days of chemotherapy cycles

Secondary Outcomes (4)

  • 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.

  • Average platelet counts

    During 21 days of chemotherapy cycles

  • Incidence of thrombocytopenia

    During 21 days of chemotherapy cycles

Study Arms (4)

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.

Drug: NL201

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.

Drug: NL201

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.

Drug: NL201Drug: rhIL-11

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.

Drug: NL201Drug: rhIL-11

Interventions

NL201DRUG

mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；

Also known as: mIL-11
A1A2
rhIL-11DRUG

rhIL-11(25μg/kg)，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.

Also known as: Recombinant Human Interleukin-11 for Injection
AB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • patients who received total body irradiation；
  • patients with childbearing potential；
  • patients who were breast-feeding or pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

The Third Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location

Related Links

MeSH Terms

Conditions

Thrombocytopenia

Interventions

oprelvekinInterleukin-11Injections

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 13, 2012

Study Start

March 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 16, 2020

Record last verified: 2017-07

Locations

CN(5)