Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

NCT00272662 | Completed Phase 2

• 2 other identifiers: AFX01-052005-003354-10
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 10

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Cohort 2

EXPERIMENTAL

Peginesatide starting dose of 0.15 mg/kg administered SC Q3W for a total of 4 doses.

Drug: peginesatide

Cohort 3

EXPERIMENTAL

Peginesatide starting dose of 0.2 mg/kg administered SC Q3W for a total of 4 doses.

Drug: peginesatide

Cohort 4

EXPERIMENTAL

Peginesatide starting dose of 0.05 mg/kg administered SC Q3W for a total of 4 doses.

Drug: peginesatide

Interventions

peginesatide DRUG

Also known as: Omontys, Hematide, AF37702 Injection

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Affymax: lead

Study Sites (10)

Research Facilities

Brno, Czechia

Location

Research Facility

Hradec Králové, Czechia

Location

Research Facility

Olomouc, Czechia

Location

Research Facility

Příbram, Czechia

Location

Research Facility

Gdansk, Poland

Location

Research Facilities

Krakow, Poland

Location

Research Facility

Lodz, Poland

Location

Research Facility

Poznan, Poland

Location

Research Facility

Szczecin, Poland

Location

Research Facilities

London, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Anemia

Interventions

peginesatide; hematide

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Affymax

  Affymax, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2006
• First Posted: January 9, 2006
• Study Start: January 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

CZ (4); GB (1); PL (5)