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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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Chemotherapy Induced Anemia, Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of participants with a hemoglobin increase of ≥ 1 gram per deciliter (g/dL) at 9 weeks following Dose 1

Outcome Time Frame:

Week 9 post Dose 1

Safety Issue:

No

Principal Investigator

Affymax

Investigator Role:

Study Director

Investigator Affiliation:

Affymax, Inc

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

AFX01-05

NCT ID:

NCT00272662

Start Date:

January 2006

Completion Date:

June 2007

Related Keywords:

  • Chemotherapy Induced Anemia
  • Cancer
  • 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
  • Anemia

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