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

NCT02692742 | Completed Phase 2 DMC

• 2 other identifiers: CT-MT001-2-2015-12015-003610-25
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 23

Brief Summary

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.

Conditions

Chemotherapy-Induced Neutropenia; Myelosuppression; Breast Cancer

Keywords

Chemotherapy; Chemotherapy-induced Neutropenia; Supportive Care; Myelosuppression; CIN

Outcome Measures

Primary Outcomes (3)

• Threshold area over the curve (AOC1) of ANC: Area below the threshold line (ANC 2.0x10^9/L classified as grade 1 neutropenia) and above the individual ANC trajectory

  visit 3 to visit 10 (22 days)

• Threshold area over the curve (AOC3) of ANC: Area below the threshold line (ANC 1.0x10^9/L classified as grade 3 neutropenia) and above the individual ANC trajectory

  visit 3 to visit 10 (22 days)

• Duration of ANC < 1.0x10^9/L classified as grade 3 neutropenia

  visit 3 to visit 10 (22 days)

Secondary Outcomes (15)

• Treatment success rate: a) Neutropenia grade ≤2, b) No need for G-CSF rescue therapy, c) No early withdrawal (drop-out).

  visit 3 to visit 10 (22 days)

• Threshold AOC of ANC (AOC4): Area below the threshold line (ANC 0.5x10^9/L classified as grade 4 neutropenia) and above the individual ANC trajectory

  visit 3 to visit 10 (22 days)

• Change of Threshold Area over the Curve of lymphocytes

  visit 3 to visit 10 (22 days)

• Change of Threshold Area over the Curve of leukocytes

  visit 3 to visit 10 (22 days)

• Change of Threshold Area over the Curve of thrombocytes

  visit 3 to visit 10 (22 days)

Study Arms (2)

Myelo001

EXPERIMENTAL

Myelo001 100 mg QD

Drug: Myelo001

Placebo

PLACEBO COMPARATOR

Matching Placebo QD

Drug: Placebo

Interventions

Myelo001 DRUG

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

Myelo001

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient of any racial origin having fulfilled her 18th birthday on Visit 1 (Screening)
• Histologically confirmed invasive breast cancer scheduled for neoadjuvant or adjuvant chemotherapy (patient with primary wound healing (\[R0\])
• 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)
• Risk of chemotherapy-induced Febrile Neutropenia ≤20% according to ASCO Guidelines (2015)
• More than 5 days remaining before the planned initiation of the 1st chemotherapy cycle
• Performance status Grade 0-1 (ECOG)
• Echocardiography: No contraindication for the scheduled chemotherapy
• 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
• Able to read, understand and willing to sign the informed consent form
• Able to undergo the investigations and to follow the Visit schedule

You may not qualify if:

• Suspected allergy to Myelo001 or its excipients
• Prior chemotherapy
• Prior or concomitant treatment with radiotherapy
• Currently on or scheduled for other immunomodulatory or immunosuppressive therapies (e.g. TNF inhibitors) during the first chemotherapy cycle
• Currently on or scheduled for other immunostimulatory or hematopoietic active therapies (e.g.G-CSF, GM-CSF)
• Currently on or scheduled for primary prophylaxis with antibiotics in the first chemotherapy cycle
• History of bone marrow transplantation or stem cell transplant
• 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.
• Already confirmed HIV, hepatitis B or C virus (HBV or HCV) infection
• History of somatic disease/condition that may interfere with the objectives of the study
• Any other medical disease or clinical laboratory parameter outside the normal range and of clinical significance according to the investigator
• Serious uncontrolled comorbidities
• Pregnant or breast-feeding subject
• Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study.

Sponsors & Collaborators

• Myelo Therapeutics GmbH: lead

Study Sites (23)

Site 20

Aachen, Germany

Location

Site 16

Aurich, Germany

Location

Site 21

Dresden, Germany

Location

Site 26

Dresden, Germany

Location

Site 05

Erlangen, Germany

Location

Site 09

Esslingen am Neckar, Germany

Location

Site 02

Frankfurt a.M., Germany

Location

Site 13

Frankfurt a.M., Germany

Location

Site 01

Friedrichshafen, Germany

Location

Site 25

Goslar, Germany

Location

Site 11

Hamburg, Germany

Location

Site 10

Hanover, Germany

Location

Site 22

Hanover, Germany

Location

Site 07

Konstanz, Germany

Location

Site 29

Lübeck, Germany

Location

Site 03

Mainz, Germany

Location

Site 23

Mainz, Germany

Location

Site 04

Offenbach, Germany

Location

Site 19

Oldenburg, Germany

Location

Site 17

Ravensburg, Germany

Location

Site 24

Rosenheim, Germany

Location

Site 28

Tübingen, Germany

Location

Site 12

Westerstede, Germany

Location

Related Links

• Company homepage

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dirk Pleimes, MD

  Myelo Therapeutics GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (23)