anemia of chronic disease in patients with cancer MedDRA version: 16.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864 MedDRA version: 16.0 Level: LLT Classification code 10054310 Term: Anemia of chronic disease System Organ Class: 100000004851
Conditions
Interventions
Product Name: NOX-H94 Hepcidin Antagonist
Product Code: NOX-H94
Pharmaceutical Form: Solution for injection
CAS Number: 1322069-19-1
Current Sponsor code: NOX-H94
Other descriptive name: NOX-H94 Hepci
Sponsors
NOXXON Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following inclusion criteria will be checked at the screening visit: 1. Written informed consent 2. Female or male aged >18 years 3. Clinically significant anemia of chronic disease (ACD) attributed to histologically or cytologically proven malignancy, either hematological or solid tumor, of any grade or stage: • Hemoglobin (Hb) 7.0 g/dL to 10 g/dL, • Transferrin saturation (TSAT) 30 ng/mL (SI: >30 µg/L) 4. Eastern Cooperative Oncology Group (ECOG) performance status of =2 5. Estimated life expectancy =12 weeks 6. Men must agree to follow effective contraception methods during treatment and for 3 months after completion of treatment. Women of childbearing potential must agree to use two forms of effective contraception during treatment and for 3 months after completion of treatment. 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: The following exclusion criteria will be checked at the screening visit. In addition, exclusion criteria 16 to 20 will be checked again at Visit 2 prior to randomization / first study drug administration 1. Inability to personally provide written informed consent or to understand and collaborate throughout the study 2. History of pure red cell aplasia, thalassemia major or sickle cell disease 3. History of anemia unrelated to cancer 150 mmHg or diastolic BP >100 mmHg; myocardial infarction or unstable angina pectoris) within 6 months prior to screening 16. Positive pregnancy test (serum ß-hCG at screening, urine pregnancy test prior to first treatment) or lactation 17. Previous treatment with NOX H94 or treatment with an investigational agent 500 mL (measured or estimated) within 6 weeks prior to treatment start 19. Treatment with ESAs or RBC transfusions <21 days prior to treatment start 20. Cytotoxic anti-tumor treatment <21 days prior to treatment start or planned during the anticipated study period (within 3 months from treatment start or randomization). Maintenance therapy is permitted throughout the study (lenalidomide up to 15 mg/d, thalidomide 50 mg per day, bortezomib once every 2 weeks, rituximab, interferon)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the response rate of anemia in patients with cancer to treatment with NOX-H94.;Secondary Objective: - To determine the safety and tolerability of NOX-H94 - To study the correlation between the exposure to NOX H94 with treatment response and with PD parameters.;Primary end point(s): Number of treatment responders as defined by either of the following criteria at any time up to 1 week after end of treatment: - Hb increase =1 g/dL - Reticulocyte index normalization (=1%) And absence of all of the following treatment failure criteria until 1 week after the end of treatment: - Patients receiving RBC transfusion, ESA, or IV iron - Hb drop by =1 g/dL - Treatment interruption due to AE;Timepoint(s) of evaluation of this end point: 8 days (V4), 15 days (V6), 22 days (V8), 29 days (V10) and 85 days (V14) from start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: - absolute values and change from baseline at each study visit of - Hb, serum iron, transferrin, ferritin, transferrin saturation ( TSAT), reticulocyte counts, RBC; soluble transferrin receptor (sTFR) and reticulocyte hemoglobin content (CHr) where available from local laboratory. - Hepcidin - Proportion of treatment responders at study visits V4, V6, V8, and V10 to V14, as defined for the primary efficacy endpoint - Proportion of treatment failures at study visits V4, V6, V8, and V10, as defined for the primary efficacy endpoint Safety and tolerability The following safety parameters will be evaluated: at screening or at randomization prior to first investigational medicinal product (IMP) administration and then as defined below and as outlined in the study flow-chart. - Vital signs and spontaneously reported adverse events will be recorded at all study visits. - 12-lead ECG at screening (Visit 1), after dosing at Visit 2 and Visit 10; additional ECGs will be recorded at the discretion of the investigator or if clinically significant changes from baseline were noted. - Safety laboratory examinations (full blood cell count, clinical chemistry) will be done at screening (Visit 1), prior to Doses 1, 3, 5, 7, and 9 (Visits 2, 4, 6, 8, and 10) and after 1 week (Visit 11), 2 weeks (Visit 12) and 4 weeks (Visit 13) of follow up after treatment. Hematology: same parameters as used for efficacy assessment: EDTA-tube; RBC, Hb, packed cell volume (PCV), MCV, MCH, mean cell hemoglobin concentration MCHC, WBC, reticulocytes, differential blood count and platelet count. Clinical chemistry: serum separator tube; AP, ALT, AST, Gamma-GT, creatine kinase, LDH, albumin, total bilirubin, urea-N, creatinine, calcium, sodium, potassium, total protein, protein electrophoresis, chloride, inorganic phosphorus, uric acid, CRP, and glucose. Immunogenicity serum samples will be tak | — |
Countries
Austria, Bulgaria
Contacts
Public ContactClinical Operations
Pierrel Research Europe GmbH
Outcome results
None listed