A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered AF37702 Injection (HematideTM) in Anemic Cancer Patients Receiving Chemotherapy - AFX01-05

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

The subject has signed a written, witnessed informed consent. Males or females, including women of childbearing potential on a highly effective method of birth control, age 18 - 80 years. Hemoglobin =8 and < 11 g/dL within 1 week prior to administration of study drug in patients who will receive at least 9 weeks of myelosuppressive chemotherapy for a histologically confirmed solid tumor malignancy or lymphoma. ECOG performance status 0-2. Within 4 weeks prior to study drug administration, one transferrin saturation =20%, serum or red cell folate level and one serum vitamin B12 level above the lower limit of normal. One reticulocyte hemoglobin content (CHr) > 29 pg within 4 weeks prior to study drug administration. Within 1 week prior to study drug administration, one absolute neutrophil count = 1.0 x10^9/L and one platelet count =75 x10^9/L. Life expectancy > 6 months.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Treatment with any erythropoiesis stimulating agent (ESA) in the past 90 days, history of failure to respond to ESA treatment, known antibodies to other ESAs or history of PRCA. Acute or chronic leukemia, myelodysplastic syndrome or multiple myeloma, previous or planned radiotherapy to more than 50% of either the pelvis or spine. Known intolerance to parenteral iron supplementation, RBC transfusion within 4 weeks prior to study drug administration, known hemoglobinopathy or hemolysis. History of pulmonary embolism or DVT in the previous 2 years or current therapeutic doses of anticoagulants. Known blood loss as a cause of anemia, uncontrolled or symptomatic inflammatory disease, AST or ALT > 2.5 times the upper limit of normal or > 5 times the upper limit of normal if liver metastases are present, creatinine > 175 µmol/L. History of bone marrow or peripheral blood cell transplantation, pyrexia/fever of = 39 °C within 48 hours prior to study drug administration, poorly controlled hypertension, epileptic seizures, advanced CHF (NYHA Class IV), likelihood of early withdrawal or interruption of study due to conditions such as of MI within the past 3 months, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric or neurological abnormalities, liver disease including active hepatitis B and hepatitis C, active HIV disease, or other diseases within the past 6 months that may interfere with patient assessment or follow-up. Anticipated elective surgery during the study period, history of multiple drug allergies, exposure to any investigational agent within 1 month prior to administration of study drug or planned receipt during the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials