Phase IIa study to investigate the efficacy of NOX-H94 in the treatment of anemia in patients with cancer.

Conditions: anemia of chronic disease in patients with cancer
MedDRA version: 16.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864
MedDRA version: 16.0Level: LLTClassification code 10054310Term: Anemia of chronic diseaseSystem Organ Class: 100000004851
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2012-001525-27-AT

Lead Sponsor: OXXON Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 48

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) <50%,
• Serum iron <50 µg/dL (SI: <9.0 µmol/L)
• Ferritin >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

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 <10 g/dL within 6 months prior to screening
4. Uncorrected iron deficiency
5. Regular need for blood transfusions at intervals <6 weeks
6. Acute or myeloid leukemia
7. Known or suspected chronic bleeding
8. Tumor with gastro-intestinal involvement without negative test for fecal occult blood
9. Suspected or known history of hemochromatosis
10. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C
11. Impaired liver function with bilirubin =2.0 mg/dL (26 µmol/L) or AST =2 times upper limit or ALT =2 times upper limit
12. History or risk of significant hepatic disease, e.g. chronic alcohol abuse, hepatic steatosis, hepatic cirrhosis, or organ transplantation
13. Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min (Cockcroft-Gault)
14. Known central nervous system malignancy or metastasis
15. Significant cardiac disease (e.g. uncontrolled hypertension: systolic blood pressure [BP] >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 <30 days prior to screening
18. Hemolysis or bleeding >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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- 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:<br>- Hb increase =1 g/dL<br>- Reticulocyte index normalization (=1%)<br>And absence of all of the following treatment failure criteria until 1 week after the end of treatment:<br>- Patients receiving RBC transfusion, ESA, or IV iron<br>- Hb drop by =1 g/dL<br>- 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 Outcome Measures

Name	Time	Method

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