EUCTR2012-001525-27-AT
Active, not recruiting
Not Applicable
Phase IIa study to characterize the effects of the Spiegelmer® NOX-H94 on anemia of chronic disease in patients with cancer
OXXON Pharma AG0 sites48 target enrollmentMay 7, 2012
Conditionsanemia of chronic disease in patients with cancerMedDRA version: 16.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10054310Term: Anemia of chronic diseaseSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- anemia of chronic disease in patients with cancer
- Sponsor
- OXXON Pharma AG
- Enrollment
- 48
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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) \<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
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
Outcomes
Primary Outcomes
Not specified
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