Clinical trial NCT00272662: Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy Induced Anemia
Cancer
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
Lead sponsor: Affymax
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of participants with a hemoglobin increase of ≥ 1 gram per deciliter (g/dL) at 9 weeks following Dose 1
timeFrame: Week 9 post Dose 1
Secondary outcomes:
measure: Incidence of adverse events and serious adverse events
timeFrame: 13 Weeks
measure: Time to achieve hemoglobin increase ≥ 1 g/dL from baseline
timeFrame: Baseline to Week 13
measure: Proportion of participants with a hemoglobin response
timeFrame: 13 Weeks
measure: Pharmacokinetic parameters
timeFrame: 13 Weeks
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Research Facilities
city: Hradec Kralove
country: Czech Republic
facility: Research Facility
city: Olomouc
country: Czech Republic
facility: Research Facility
city: Pribram
country: Czech Republic
facility: Research Facility
city: Gdańsk
country: Poland
facility: Research Facility
city: Krakow
country: Poland
facility: Research Facilities
city: Lodz
country: Poland
facility: Research Facility
city: Poznań
country: Poland
facility: Research Facility
city: Szczecin
country: Poland
facility: Research Facility
city: London
country: United Kingdom
facility: Research Facilities
Study officials:
affiliation: Affymax, Inc
name: Affymax
role: STUDY_DIRECTOR
References: