Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

Sponsor

Affymax (Industry)

Overall Status

Completed

CT.gov ID

NCT00272662

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy Induced Anemia Cancer	Drug: peginesatide	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 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.	Drug: peginesatide Other Names: Omontys Hematide AF37702 Injection
Experimental: Cohort 2 Peginesatide starting dose of 0.15 mg/kg administered SC Q3W for a total of 4 doses.	Drug: peginesatide Other Names: Omontys Hematide AF37702 Injection
Experimental: Cohort 3 Peginesatide starting dose of 0.2 mg/kg administered SC Q3W for a total of 4 doses.	Drug: peginesatide Other Names: Omontys Hematide AF37702 Injection
Experimental: Cohort 4 Peginesatide starting dose of 0.05 mg/kg administered SC Q3W for a total of 4 doses.	Drug: peginesatide Other Names: Omontys Hematide AF37702 Injection

Outcome Measures

Primary Outcome Measures

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

Incidence of adverse events and serious adverse events [13 Weeks]
Time to achieve hemoglobin increase ≥ 1 g/dL from baseline [Baseline to Week 13]
Proportion of participants with a hemoglobin response [13 Weeks]
Pharmacokinetic parameters [13 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Research Facilities	Brno	Czech Republic
2	Research Facility	Hradec Kralove	Czech Republic
3	Research Facility	Olomouc	Czech Republic
4	Research Facility	Pribram	Czech Republic
5	Research Facility	Gdańsk	Poland
6	Research Facilities	Krakow	Poland
7	Research Facility	Lodz	Poland
8	Research Facility	Poznań	Poland
9	Research Facility	Szczecin	Poland
10	Research Facilities	London	United Kingdom