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Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Cancer

Phase 2
18 Years
Open (Enrolling)
Anemia of Chronic Disease

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Trial Information

Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Cancer

Inclusion Criteria:

- Written informed consent

- Female or male aged >18 years

- 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), AND Ferritin >30 ng/mL (SI: >30 µg/L)

- Previous treatment with systemic anti-cancer therapy / regimen

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

- Estimated life expectancy ≥12 weeks

- 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.

Exclusion Criteria:

- Inability to personally provide written informed consent or to understand and
collaborate throughout the study

- History of pure red cell aplasia, thalassemia major or sickle cell disease History of
anemia unrelated to cancer <10 g/dL within 6 months prior to screening

- Uncorrected iron deficiency

- Regular need for blood transfusions at intervals <6 weeks

- Acute or myeloid leukemia

- Known or suspected chronic bleeding

- Tumor with gastro-intestinal involvement without negative test for fecal occult blood

- Suspected or known history of hemochromatosis

- Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C

- Impaired liver function with bilirubin ≥2.0 mg/dL (26 μmol/L), AST or ALT ≥2 times
upper limit

- History or risk of significant hepatic disease, e.g. chronic alcohol abuse, hepatic
steatosis, hepatic cirrhosis, or organ transplantation

- Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min

- Known central nervous system malignancy or metastasis

- 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

- Positive pregnancy test (serum ß-hCG at screening, urine pregnancy test prior to
first treatment) or lactation

- Previous participation in this study or treatment with an investigational agent <21
days prior to treatment start

- Hemolysis or bleeding >500 mL (measured or estimated) within 6 weeks prior to
treatment start

- Treatment with erythropoiesis-stimulating agents (ESAs) or red blood cell (RBC)
transfusions <21 days prior to treatment start

- 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 (e.g. lenalidomide,

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Response rate of anemia

Outcome Description:

• Hb increase ≥1 g/dL OR reticulocyte index normalization (≥1%) at any time point until 1 week after the end of treatment AND absence of all of the following treatment failure criteria until 1 week after the end of treatment: Erythrocyte transfusion, ESA or IV iron, Hb drop by ≥1 g/dL Treatment interruption due to adverse events (AEs)

Outcome Time Frame:

treatment start to 1 week after treatment end

Safety Issue:


Principal Investigator

Kai Riecke, MD

Investigator Role:

Study Director

Investigator Affiliation:

Noxxon Pharma AG


Austria: Federal Office for Safety in Health Care

Study ID:




Start Date:

September 2012

Completion Date:

September 2013

Related Keywords:

  • Anemia of Chronic Disease
  • Hepcidin
  • Iron
  • Anemia of Chronic Disease
  • Anemia
  • Cancer
  • Interleukin-6
  • Iron restriction
  • Lymphoma
  • CLL
  • Multiple Myeloma
  • Hodgkin
  • anti-hepcidin
  • Anemia
  • Chronic Disease