study of subcutaneously administered peginesatide in anemic cancer patients receiving chemotherapy

Conditions: Chemotherapy Induced Anemia; Cancer

Summary: the purpose of this study is to evaluate the safety, pharmacodynamics (pd), and pharmacokinetics (pk) of multiple subcutaneously administered injections of peginesatide in anemic cancer participants receiving chemotherapy.

this was a phase 2, open-label, multi-center, sequential dose finding study with up to 6 treatment cohorts receiving chemotherapy with 15 participants per cohort. the primary objective of this study was to determine the dose of peginesatide administered every 3 weeks (q3w) by subcutaneous injection associated with a hemoglobin increase of ≥ 1 g/dl in ≥ 50% of anemic cancer participants receiving chemotherapy at 9 weeks following the first dose.

Eligibility criteria:
inclusion criteria: * participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines * males or females ≥ 18 and ≤ 80 years of age; pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 2 weeks prior to study start, and must be willing to continue practicing birth control for at least 4 weeks after the last dose of study drug. a highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some iuds, sexual abstinence (only acceptable if practiced as a life-style and not acceptable if one who is sexually active practices abstinence only for the duration of study) or vasectomized partner * participants with histologically confirmed solid tumor malignancy or lymphoma who are scheduled to receive at least 9 weeks of cyclic myelosuppressive chemotherapy while on study * hemoglobin value of ≥ 8 and \< 11 g/dl within 1 week prior to administration of study drug. * ecog performance status of 0-2 * one reticulocyte hemoglobin content (chr) \> 29 picograms within 4 weeks prior to study drug administration. * one transferrin saturation ≥ 15% within 4 weeks prior to study drug administration. * one serum or red cell folate level above the lower limit of normal within 4 weeks prior to study drug administration * one vitamin b12 level above the lower limit of normal within 4 weeks prior to study drug administration * one absolute neutrophil count ≥ 1.0 x 10\^9/l within 1 week prior to administration of study drug * one platelet count ≥ 75 x 10\^9/l within 1 week prior to administration of study drug * life expectancy \> 6 months. 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 pure red cell aplasia (prca) * acute or chronic leukemia, myelodysplastic syndrome (mds), or multiple myeloma * any previous or planned radiotherapy to more than 50% of either the pelvis or spine * known intolerance to parenteral iron supplementation * red blood cell transfusion within 4 weeks prior to study drug administration * known hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.) * known hemolysis * history of pulmonary embolism or deep venous thrombosis (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 (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.) * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 2.5 times the upper limit of normal; ast or alt \> 5 times the upper limit of normal if liver metastases are present. * creatinine \> 175 micromoles per liter (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, per the investigator's judgment, within 4 weeks prior to study drug administration (e.g., systolic ≥ 170 mm hg or diastolic ≥ 100 mm hg on repeat readings) * epileptic seizure in the 6 months prior to study drug administration * advanced chronic congestive heart failure - new york heart association class iv * high likelihood of early withdrawal or interruption of the study * 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 period.

Keywords: anemia cancer chemotherapy chemotherapy induced anemia cia hemoglobin hb hgb erythropoietin epo erythropoiesis stimulating agent esa hematide omontys peginesatide red blood cell red blood cell production