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    Summary
    EudraCT Number:2005-003354-10
    Sponsor's Protocol Code Number:AFX01-05
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-003354-10
    A.3Full title of the trial
    A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered AF37702 Injection (HematideTM) in Anemic Cancer Patients Receiving Chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    AFX01-05
    A.4.1Sponsor's protocol code numberAFX01-05
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAffymax, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAF37702 Injection
    D.3.2Product code AF37702, Hematide
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet received
    D.3.9.1CAS number Not given
    D.3.9.2Current sponsor codeAF37702
    D.3.9.3Other descriptive nameHematide
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anemia in cancer patients receiving chemotherapy.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the AF37702 dose administered every 3 weeks by subcutaneous injection that is associated with a hemoglobin increase of ≥1 g/dL in ≥50% of anemic cancer patients receiving chemotherapy at 9 weeks after Dose 1.
    E.2.2Secondary objectives of the trial
    To evaluate the safety, pharmacokinetic, and pharmacodynamic profiles of up to four doses of AF37702 administered subcutaneously every 3 weeks in cancer patients receiving concomitant myelosuppressive chemotherapy.
    To determine the change from baseline in Hgb in anemic cancer patients receiving chemotherapy at different dose levels of AF37702.
    To determine the proportion of patients who have a Hgb response to AF37702.
    To determine the dose of AF37702 administered subcutaneously that increases and maintains hemoglobin in the target range of 11-13 g/dL in anemic cancer patients receiving chemotherapy.
    To evaluate the pharmacokinetic profile of up to 4 doses of AF37702 administered subcutaneously in anemic cancer patients receiving chemotherapy (in a subset of study patients).
    To explore the effect of dose frequency at an active dose of AF37702 (optional)
    To explore the effect of parenteral iron replacement at an active dose of AF37702 (optional).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The subject has signed a written, witnessed informed consent. Males or females, including women of childbearing potential on a highly effective method of birth control, age 18 - 80 years. Hemoglobin ≥8 and < 11 g/dL within 1 week prior to administration of study drug in patients who will receive at least 9 weeks of myelosuppressive chemotherapy for a histologically confirmed solid tumor malignancy or lymphoma. ECOG performance status 0-2. Within 4 weeks prior to study drug administration, one transferrin saturation ≥20%, serum or red cell folate level and one serum vitamin B12 level above the lower limit of normal. One reticulocyte hemoglobin content (CHr) > 29 pg within 4 weeks prior to study drug administration. Within 1 week prior to study drug administration, one absolute neutrophil count ≥ 1.0 x10^9/L and one platelet count ≥75 x10^9/L. Life expectancy > 6 months.
    E.4Principal 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 PRCA. Acute or chronic leukemia, myelodysplastic syndrome or multiple myeloma, 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 or 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, AST or ALT > 2.5 times the upper limit of normal or > 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, epileptic seizures, advanced CHF (NYHA Class IV), likelihood of early withdrawal or interruption of study due to conditions such as of MI within the past 3 months, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric or neurological abnormalities, liver disease including active hepatitis B and hepatitis C, active HIV disease, or other diseases within the past 6 months that may interfere with patient assessment or follow-up. 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.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients per treatment group who have a Hgb increase ≥1 g/dL from baseline at 9 weeks after Dose 1 in the absence of RBC transfusion in the previous 28 days. Proportion of patients per treatment group who have a Hgb increase ≥1 g/dL from baseline at 3, 6, and 12 weeks after Dose 1 in the absence of RBC transfusion in the previous 28 days. Proportion of patients per treatment group who have a Hgb response that is ≥2 g/dL from baseline or an increase of ≥1 g/dL to at least 12 g/dL at weeks 3, 6, 9, 12 after Dose 1 in the absence of RBC transfusion in the previous 28 days. Proportion of patients per treatment group who have Hgb values in the target range of 11-13 g/dL at weeks 3, 6, 9, 12 after Dose 1. Average per patient proportion of Hgb values in the target range of 11-13 g/dL 3, 6, 9, 12 weeks following Dose 1. Average Hgb change from baseline at weeks 3, 6, 9, 12 after Dose 1. Frequency of RBC transfusions after week 4. Additional pharmacologic parameters such as reticulocyte counts. Changes in measure of iron status. Adverse events and serious adverse events.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined as the last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-08-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-18
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