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Study of Subcutaneously Administered Hematide™ in Anemic Cancer Patients Receiving Chemotherapy
This study is ongoing, but not recruiting participants.
Sponsored by: Affymax
Information provided by: Affymax
ClinicalTrials.gov Identifier: NCT00272662
  Purpose

The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneously administered injections of Hematide™ in anemic cancer patients receiving chemotherapy.


Condition Intervention Phase
Chemotherapy Induced Anemia
Cancer
Drug: Hematide™
Phase II

MedlinePlus related topics: Anemia Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Hematide™ in Anemic Cancer Patients Receiving Chemotherapy

Further study details as provided by Affymax:

Primary Outcome Measures:
  • Primary objective of this study is to determine the dose of Hematide™ administered every three weeks by subcutaneous (SC) injection associated with a hemoglobin increase of ≥ 1 g/dL in ≥ 50% of anemic cancer patients receiving chemotherapy at 9 week [ Time Frame: 13 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the safety profile of up to 4 doses of Hematide™ administered subcutaneously every three weeks in cancer patients receiving concomitant myelosuppressive chemotherapy [ Time Frame: 13 Weeks ] [ Designated as safety issue: Yes ]
  • Determine the change from baseline in hemoglobin (Hgb) in anemic cancer patients receiving chemotherapy at different dose levels of Hematide™ [ Time Frame: 13 Weeks ] [ Designated as safety issue: Yes ]
  • Determine the proportion of patients who have a Hgb response to Hematide™ [ Time Frame: 13 Weeks ] [ Designated as safety issue: Yes ]
  • Determine the dose of Hematide™ administered subcutaneously that increases and maintains the hemoglobin in the target range of 11-13 g/dL in anemic cancer patients receiving chemotherapy [ Time Frame: 13 Weeks ] [ Designated as safety issue: Yes ]
  • Evaluate the pharmacokinetic profile of up to 4 doses of Hematide™ administered subcutaneously in anemic cancer patients receiving chemotherapy (in a subset of study patients) [ Time Frame: 13 Weeks ] [ Designated as safety issue: Yes ]
  • Explore the effect of dose frequency at an active dose of Hematide™ [ Time Frame: 13 Weeks ] [ Designated as safety issue: Yes ]
  • Explore the effect of parenteral iron replacement at an active dose of Hematide™ [ Time Frame: 13 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: December 2005
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: No Intervention Drug: Hematide™
Injection
II: No Intervention Drug: Hematide™
Injection

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient 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
  • Patients 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 pg 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.

If the patient is considered by the Investigator as iron-deficient and IV iron supplementation is required, patient must be re-screened weekly (no sooner than 7 days after iron administration) until hemoglobin has not increased more than 0.5 g/dL from the previous week.*

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
  • RBC 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 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.)
  • AST or 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 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 (e.g., myocardial infarction within the past 3 months; severe or unstable coronary artery disease; stroke; respiratory, autoimmune, neuropsychiatric or neurological abnormalities; liver disease including active hepatitis B or C; active HIV disease; or any other clinically significant medical diseases or conditions within the prior 6 months that may, in the Investigator's opinion, interfere with assessment or follow-up of the patient)
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272662

Locations
Czech Republic
Research Facility
Brno, Czech Republic
Research Facility
Olomouc, Czech Republic
Research Facility
Hradec Kralove, Czech Republic
Research Facility
Pribram, Czech Republic, 261 01
Research Facility
Praha 2, Czech Republic, 128 08
Poland
Research Facility
Poznań, Poland
Research Facility
Szczecin, Poland
Research Facility
Opole, Poland
Research Facility
Krakow, Poland
Research Faciliy
Gdańsk, Poland
Research Facility
Krakow, Poland, 31-826
Research Facility
Ul. Okolna 181, Poland, 91-520 Lodz
Research Facility
Warszawa, Poland, 00-909
United Kingdom
Research Facility
London, United Kingdom
Research Facility
Manchester, United Kingdom
Sponsors and Collaborators
Affymax
Investigators
Study Director: Chief Medical Officer Affymax, Inc
  More Information

Responsible Party: Affymax, Inc. ( Chief Medical Officer )
Study ID Numbers: AFX01-05
Study First Received: January 5, 2006
Last Updated: April 28, 2008
ClinicalTrials.gov Identifier: NCT00272662  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Affymax:
Anemia
cancer
hemoglobin
Anemia in cancer patients

Study placed in the following topic categories:
Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on January 16, 2009