A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.

Inclusion Criteria:

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

• Individuals with one of the following histologically confirmed tumors:

  • stage IIIB/IV non-small-cell lung cancer
  • metastatic breast cancer
  • androgen insensitive prostate cancer and are scheduled to receive at least 4 weeks of chemotherapy, including a taxane.
• Has progression or relapse after treatment with at least one regimen of chemotherapy or hormone therapy.
• Has a hemoglobin value of greater than or equal to 8 and less than 10.5 g/dL within 1 week prior to administration of study drug.
• Has an Eastern Cooperative Oncology Group Performance Status of 0-2.
• Has one ferritin level greater than or equal to 100 ng/mL within 4 weeks prior to study drug administration.
• Has one serum or red cell folate level above the lower limit of normal within 4 weeks prior to study drug administration.
• Has one vitamin B12 level above the lower limit of normal within 4 weeks prior to study drug administration.
• Has one absolute neutrophil count greater than or equal to 1.5 x 109/L within 1 week prior to administration of study drug.
• The subject has a serum creatinine less than or equal to 1.5 mg/dL or a measured creatinine clearance greater than 60 mL/min.
• The subject has one platelet count greater than or equal to 100 x 109/L within 1 week prior to administration of study drug.
• The subject has a Life expectancy greater than 4 months.
• The subject has a body mass index between 18 and 30 kg/m2, inclusive, prior to study drug administration.
• The subject has a negative test result for hepatitis B surface antigen, and hepatitis C virus antibody at Screening.

Exclusion Criteria:

• Has a history of failure to respond to erythropoiesis-stimulating agent treatment.
• Has had treatment with any erythropoiesis-stimulating agent in the past 4 weeks.
• Is known to have antibodies to other erythropoiesis-stimulating agents or history of Pure Red Cell Aplasia.
• Has received Peginesatide in a previous clinical study or as a therapeutic agent.
• Has a history of hypersensitivity or allergies to Peginesatide, other erythropoiesis-stimulating agents or related compounds.
• Has had red blood cell transfusion within 4 weeks prior to study drug administration.
• Has known hemoglobinopathy (eg, homozygous sickle-cell disease, thalassemia of all types, etc).
• Has known hemolytic condition.
• Has known blood loss as a cause of anemia, iron deficiency anemia, or anemia caused by gastrointestinal bleeding.
• Has any previous or planned radiotherapy to more than 30% of active bone marrow.
• Has donated more than 400 mL of blood within the 90 days preceding the beginning of the study.
• Has known intolerance to parenteral iron supplementation.
• Has received IV iron within 1 week of study drug administration.
• Has history of bone marrow or peripheral blood cell transplantation.
• Has central nervous system metastases.
• Has a history of deep venous thrombosis, pulmonary embolism or other thrombotic event (eg, stroke, myocardial infarction, etc.) in the previous 6 months or known history of hypercoagulable disorder.
• Has uncontrolled, or symptomatic inflammatory disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc).
• Has poorly controlled hypertension per the investigator's judgment within 4 weeks prior to study drug administration (eg, systolic greater than or equal to 170 mm Hg or diastolic greater than or equal to 100 mm Hg on repeat readings).
• Has had a seizure in the 6 months prior to study drug administration.
• Has advanced chronic congestive heart failure - New York Heart Association Class III or IV.
• Has a history or presence of an abnormal electrocardiogram at Screening that, in the investigator's opinion, is clinically significant.
• Has a known history of human immunodeficiency virus.
• Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as consumption of more than 4 alcoholic drinks per day) within 1 year prior to Baseline.
• Has aspartate aminotransferase or alanine aminotransferase greater than 2.5 times the upper limit of normal (aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper limit of normal if liver metastases are present), active liver disease or jaundice.
• Is currently taking or anticipated to require anticoagulants other than aspirin (eg, coumadin, ticlopidine, etc.).
• Has a bilirubin greater than the upper limit of normal.
• Has pyrexia/fever greater than or equal to 39°C within 48 hours prior to study drug administration.
• Has high likelihood of early withdrawal or interruption of the study (eg, myocardial infarction within the past 3 months, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric or neurological abnormalities, or any other clinically significant medical diseases or conditions within the prior 6 months that may, in the investigator's opinion, interfere with assessment or follow-up of the subject).
• Has anticipated elective surgery during the study period.
• Has exposure to any investigational agent within 1 month prior to administration of study drug or planned receipt during the study period.