Anemia in cancer patients receiving chemotherapy.
Conditions
Interventions
Product Name: AF37702 Injection
Product Code: AF37702, Hematide
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not yet received
Sponsors
Affymax, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the AF37702 dose administered every 3 weeks by subcutaneous injection that is associated with a hemoglobin increase of =1 g/dL in =50% of anemic cancer patients receiving chemotherapy at 9 weeks after Dose 1.; Secondary Objective: To evaluate the safety, pharmacokinetic, and pharmacodynamic profiles of up to four doses of AF37702 administered subcutaneously every 3 weeks in cancer patients receiving concomitant myelosuppressive chemotherapy. To determine the change from baseline in Hgb in anemic cancer patients receiving chemotherapy at different dose levels of AF37702. To determine the proportion of patients who have a Hgb response to AF37702. To determine the dose of AF37702 administered subcutaneously that increases and maintains hemoglobin in the target range of 11-13 g/dL in anemic cancer patients receiving chemotherapy. To evaluate the pharmacokinetic profile of up to 4 doses of AF37702 administered subcutaneously in anemic cancer patients receiving chemotherapy (in a subset of study patients). To explore the effect of dose frequency at an active dose of AF37702 (optional) To explore the effect of parenteral iron replacement at an active dose of AF37702 (optional). ;Primary end point(s): Proportion of patients per treatment group who have a Hgb increase =1 g/dL from baseline at 9 weeks after Dose 1 in the absence of RBC transfusion in the previous 28 days. Proportion of patients per treatment group who have a Hgb increase =1 g/dL from baseline at 3, 6, and 12 weeks after Dose 1 in the absence of RBC transfusion in the previous 28 days. Proportion of patients per treatment group who have a Hgb response that is =2 g/dL from baseline or an increase of =1 g/dL to at least 12 g/dL at weeks 3, 6, 9, 12 after Dose 1 in the absence of RBC transfusion in the previous 28 days. Proportion of patients per treatment group | — |
Countries
Czech Republic, United Kingdom
Outcome results
None listed