Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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22 December 2015 |
Main ID: |
EUCTR2015-002874-19-FR |
Date of registration:
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04/09/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study to Evaluate Imetelstat (JNJ-63935937) in Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS).
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Scientific title:
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A Study to Evaluate Imetelstat (JNJ-63935937) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment |
Date of first enrolment:
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23/11/2015 |
Target sample size:
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200 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002874-19 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
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Phase:
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Countries of recruitment
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Belgium
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France
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Germany
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Italy
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Korea, Republic of
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Mexico
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Netherlands
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Russian Federation
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Spain
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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+31(0)71524 21 66 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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+31(0)71524 21 66 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Man or woman greater than or equal to (>=) 18 years of age
- Diagnosis of myelodysplastic syndrome (MDS) according to WHO criteria or French-American-British (FAB) classification confirmed by bone marrow aspirate and biopsy within 12 weeks prior to Study Entry. A local laboratory report from this diagnostic bone marrow aspirate and biopsy must be reviewed and approved by the sponsor
- International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS
- Red blood cell (RBC) transfusion dependent, defined as requiring 4 units RBC over 8 weeks during the 12 weeks prior to Study Entry; pre-transfusion hemoglobin (Hb) should be less than equal to 9.0 gram per deciliter (g/dL) to count towards the 4 units total
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria: - Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients
- Participant has received an investigational drug or used an invasive investigational medicaldevice within 30 days prior to Study Entry or is currently enrolled in an investigational study
- Prior treatment with imetelstat
- Have received any chemotherapy, immunomodulatory or immunosuppressive therapy, corticosteroids greater than 30 milligram per day prednisone or equivalent, or growth factor treatment within 28 days prior to study entry
- Have received other treatments for MDS within 4 weeks prior to Study Entry
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Myelodysplastic syndrome (MDS) MedDRA version: 18.0
Level: HLT
Classification code 10028536
Term: Myelodysplastic syndromes
System Organ Class: 100000004851
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Intervention(s)
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Product Name: Imetelstat sodium Product Code: JNJ-63935937 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: Imetelstat sodium CAS Number: 1007380-31-5 Current Sponsor code: JNJ-63935937 Other descriptive name: IMETELSTAT SODIUM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 210-
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Primary Outcome(s)
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Main Objective: Part 1: To evaluate the efficacy and safety of imetelstat in transfusion dependent subjects with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment.
Part 2: To compare the efficacy, in terms of RBC TI, of imetelstat to placebo in transfusion dependent subjects with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment.
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Secondary Objective: - To assess the safety of imetelstat in subjects with MDS - To assess the time to RBC TI and duration of RBC TI - To assess the rate of hematologic improvement - To assess the rates of CR or PR - To assess OS - To assess time to progression to AML - To assess the rate and amount of supportive care, including transfusions and myeloid growth factors - To evaluate the pharmacokinetics and immunogenicity of imetelstat in subjects with MDS - To assess the effect of imetelstat treatment on patient reported outcomes (PROs) - To assess the effect of treatment on medical resource utilization
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Primary end point(s): Percentage of participants without any red blood cell (RBC) transfusion during any consecutive 8 week period.
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Timepoint(s) of evaluation of this end point: 8 weeks
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1/ up to follow-up (30 days posttreatment [approximately 2 years])
2-12/ up to 2 years after enrollment of the last participant
13-14/ During treatment (approximately 2 years)
15-16/ up to 2 years after enrollment of the last participant
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Secondary end point(s): 1/ Number of Participants with Adverse Events (AEs)
2/ Percentage of participants without any red blood cell (RBC) transfusion during any consecutive 24 week period
3/ Time to the 8-week RBC transfusion independence (TI)
4/ Duration of RBC TI
5/ Percentage of Participants with hematologic improvement
6/ Percentage of Participants with Complete remission (CR) or Partial remission (PR) as Per International Working Group (IWG) Response CriteriaI 2006
7/ Overall survival
8/ Time to Progression to Acute Myeloid Leukemia
9/ Percentage of Participants with Transfusion
10/ Amount of Transfusions
11/ Percentage of Participants receiving any myeloid growth factors
12/ Change from baseline in Functional Assessment of Cancer Therapy -Anemia-Related Effects (FACT-An) Score and EuroQol-EQ-5D-5L ESA (EQ-5D-5L) Score
13/ Maximum Observed Plasma Concentration (Cmax)
14/ Area under the drug concentrationplasma time curve from time zero to last measurable concentration (AUC0-t)
15/ Percentage of Participants with antibodies to imetelstat
16/ Medical resource utilization data
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Secondary ID(s)
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63935937MDS3001
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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