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Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia

NCT ID: NCT02692742

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-11-30

Brief Summary

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Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting the doses and density of chemotherapy that can be tolerated. The degree and duration of neutropenia determine the risk of infection. Myelo001, a small orally bioavailable molecule, has been shown in chemotherapy- or radiotherapy-induced myelosuppression to stimulate differentiation of peripheral white blood cells (WBC) and bone marrow cells of the leucocytic, lymphocytic, and erythrocytic lineage. The purpose of the MyeloConcept study is to determine the safety and effectiveness of Myelo001 in preventing or reducing chemotherapy-induced neutropenia and myelosuppression in patients receiving chemotherapy due to breast cancer.

Detailed Description

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Phase IIa study, 1:1 randomized, double-blind, placebo-controlled, parallel-design, multi-center study. Each breast cancer patient will be randomly assigned into one of two treatment arms receiving either Myelo001 or placebo as a tablet. Investigational medicinal product is taken as supportive care for 23 consecutive days during chemotherapy treatment. Hematologic and safety parameters as well as actual begin and doses of following chemotherapy cycles will be assessed. A single primary variable will be analyzed with test statistics based on frequent absolute neutrophil measurements. Additionally, in a subgroup of patients biomarkers and pharmacokinetics of Myelo001 will be investigated.

Conditions

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Chemotherapy-Induced Neutropenia Myelosuppression Breast Cancer

Keywords

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Chemotherapy Chemotherapy-induced Neutropenia Supportive Care Myelosuppression CIN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Myelo001

Myelo001 100 mg QD

Group Type EXPERIMENTAL

Myelo001

Intervention Type DRUG

Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment

Placebo

Matching Placebo QD

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment

Interventions

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Myelo001

Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment

Intervention Type DRUG

Placebo

Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female patient of any racial origin having fulfilled her 18th birthday on Visit 1 (Screening)
2. Histologically confirmed invasive breast cancer scheduled for neoadjuvant or adjuvant chemotherapy (patient with primary wound healing (\[R0\])
3. Already selected for neoadjuvant or adjuvant standard of care EC regimen (Epirubicin 90 mg/m2 BSA (body surface area) + Cyclophosphamide 600 mg/m2 BSA q21d (every 21 days)) (with or without treatment with taxanes afterwards)
4. Risk of chemotherapy-induced Febrile Neutropenia ≤20% according to ASCO Guidelines (2015)
5. More than 5 days remaining before the planned initiation of the 1st chemotherapy cycle
6. Performance status Grade 0-1 (ECOG)
7. Echocardiography: No contraindication for the scheduled chemotherapy
8. Haematologic, laboratory and chemistry thresholds at baseline:

* Absolute neutrophil count (ANC) ≥2,000 cells/ mm3 (≥2.0 x 10/L)
* Platelet count ≥100,000/mm3 (≥100 x 10exp9/L)
* Haemoglobin ≥10 g/dL
* Total bilirubin \<1.5 x, AST, ALT \<2.5 x upper limit of normal (ULN)
* Serum creatinine \<2.0 mg/dL
9. Able to read, understand and willing to sign the informed consent form
10. Able to undergo the investigations and to follow the Visit schedule

Exclusion Criteria

1. Suspected allergy to Myelo001 or its excipients
2. Prior chemotherapy
3. Prior or concomitant treatment with radiotherapy
4. Currently on or scheduled for other immunomodulatory or immunosuppressive therapies (e.g. TNF inhibitors) during the first chemotherapy cycle
5. Currently on or scheduled for other immunostimulatory or hematopoietic active therapies (e.g.G-CSF, GM-CSF)
6. Currently on or scheduled for primary prophylaxis with antibiotics in the first chemotherapy cycle
7. History of bone marrow transplantation or stem cell transplant
8. Administration of another investigational medicinal product / medical device within 30 days prior to screening. Participation in non-interventional, national or international cancer registries is allowed.
9. Already confirmed HIV, hepatitis B or C virus (HBV or HCV) infection
10. History of somatic disease/condition that may interfere with the objectives of the study
11. Any other medical disease or clinical laboratory parameter outside the normal range and of clinical significance according to the investigator
12. Serious uncontrolled comorbidities
13. Pregnant or breast-feeding subject
14. Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Myelo Therapeutics GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk Pleimes, MD

Role: STUDY_DIRECTOR

Myelo Therapeutics GmbH

Locations

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Site 20

Aachen, , Germany

Site Status

Site 16

Aurich, , Germany

Site Status

Site 21

Dresden, , Germany

Site Status

Site 26

Dresden, , Germany

Site Status

Site 05

Erlangen, , Germany

Site Status

Site 09

Esslingen am Neckar, , Germany

Site Status

Site 02

Frankfurt a.M., , Germany

Site Status

Site 13

Frankfurt a.M., , Germany

Site Status

Site 01

Friedrichshafen, , Germany

Site Status

Site 25

Goslar, , Germany

Site Status

Site 11

Hamburg, , Germany

Site Status

Site 10

Hanover, , Germany

Site Status

Site 22

Hanover, , Germany

Site Status

Site 07

Konstanz, , Germany

Site Status

Site 29

Lübeck, , Germany

Site Status

Site 03

Mainz, , Germany

Site Status

Site 23

Mainz, , Germany

Site Status

Site 04

Offenbach, , Germany

Site Status

Site 19

Oldenburg, , Germany

Site Status

Site 17

Ravensburg, , Germany

Site Status

Site 24

Rosenheim, , Germany

Site Status

Site 28

Tübingen, , Germany

Site Status

Site 12

Westerstede, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.myelotherapeutics.com

Company homepage

Other Identifiers

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2015-003610-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CT-MT001-2-2015-1

Identifier Type: -

Identifier Source: org_study_id