Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272662
• Other study ID #: AFX01-05
• Secondary ID: 2005-003354-10
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2006
• Last updated: December 19, 2012
• Start date: January 2006
• Est. completion date: June 2007

Study information

• Verified date: December 2012
• Source: Affymax
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: The Central Register of Clinical TrialsPoland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Chemotherapy Induced Anemia

Intervention

Drug:
• peginesatide

Locations

Country	Name	City	State
Czech Republic	Research Facilities	Brno
Czech Republic	Research Facility	Hradec Kralove
Czech Republic	Research Facility	Olomouc
Czech Republic	Research Facility	Pribram
Poland	Research Facility	Gdansk
Poland	Research Facilities	Krakow
Poland	Research Facility	Lodz
Poland	Research Facility	Poznan
Poland	Research Facility	Szczecin
United Kingdom	Research Facilities	London

Sponsors (1)

Lead Sponsor	Collaborator
Affymax

Countries where clinical trial is conducted

Czech Republic,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of adverse events and serious adverse events		13 Weeks	Yes
Secondary	Time to achieve hemoglobin increase = 1 g/dL from baseline		Baseline to Week 13	No
Secondary	Proportion of participants with a hemoglobin response		13 Weeks	No
Secondary	Pharmacokinetic parameters		13 Weeks	No