A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy
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.