Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy
- Registration Number
- NCT00272662
- Lead Sponsor
- Affymax
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 peginesatide Peginesatide starting dose of 0.1 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 3 weeks (Q3W) for a total of 4 doses. Cohort 2 peginesatide Peginesatide starting dose of 0.15 mg/kg administered SC Q3W for a total of 4 doses. Cohort 3 peginesatide Peginesatide starting dose of 0.2 mg/kg administered SC Q3W for a total of 4 doses. Cohort 4 peginesatide Peginesatide starting dose of 0.05 mg/kg administered SC Q3W for a total of 4 doses.
- Primary Outcome Measures
Name Time Method Percentage of participants with a hemoglobin increase of ≥ 1 gram per deciliter (g/dL) at 9 weeks following Dose 1 Week 9 post Dose 1
- Secondary Outcome Measures
Name Time Method Proportion of participants with a hemoglobin response 13 Weeks Pharmacokinetic parameters 13 Weeks Incidence of adverse events and serious adverse events 13 Weeks Time to achieve hemoglobin increase ≥ 1 g/dL from baseline Baseline to Week 13
Trial Locations
- Locations (2)
Research Facilities
🇬🇧London, United Kingdom
Research Facility
🇵🇱Szczecin, Poland