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    Summary
    EudraCT Number:2007-004787-49
    Sponsor's Protocol Code Number:A4021006
    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:2007-11-26
    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 number2007-004787-49
    A.3Full title of the trial
    A PHASE II, SINGLE ARM STUDY OF CP-751,871 IN PATIENTS WITH REFRACTORY METASTATIC ADENOCARCINOMA OF THE COLON OR RECTUM
    A.4.1Sponsor's protocol code numberA4021006
    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 SponsorPfizer Inc - 235 East 42nd Street, New York, NY 10017
    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 No
    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.3.2Product code CP-751,871
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCP-751,871
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Refractory colorectal cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate six-month overall survival in refractory, metastatic colorectal cancer patients who receive CP-751,871.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of multiple intravenous doses of CP 751,871
    To evaluate the efficacy of CP-751,871 in terms of progression free survival (PFS)
    To evaluate the efficacy of CP-751,871 in terms of overall survival (OS)
    To evaluate the efficacy of CP-751,871 in terms of objective response
    To collect pharmacokinetics (PK) data of CP 751,871 for future population PK meta-analysis
    To monitor the immunogenicity of CP 751,871 in terms of producing an anti-drug antibody (ADA) response
    To explore the feasibility of quantification of circulating tumor cells (CTCs) and that of CTCs expressing the IGF-IR
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Molecular Profiling Supplement dtd 9 August 2007

    The primary objective of this additional research component is to collect, store, and use
    samples to investigate possible associations between genomic and metabonomic variation:
    • in relation to response to the study drugs, and
    • in relation to characteristics of the disease/condition under study in the associated clinical trial, and related conditions.
    E.3Principal inclusion criteria
    1. Age >18 years
    2. Histologically or cytologically confirmed adenocarcinoma arising in the colon or rectum. Histological evaluation (new biopsy) at the time of enrollment is not required.
    3. Radiographic evidence of metastatic, progressive disease following standard therapies. Patients in the United States will have been treated previously with, or have a significant known contraindication to, a fluoropyrimidine, irinotecan and oxaliplatin. These patients may or may not have been treated with bevacizumab (Avastin), cetuximab (Erbitux) and/or Panitumumab (Vectibix). Patients outside of the United States will have been treated with, or have a contraindication to, at least 2 prior chemotherapy regimens with whichever drugs are routinely used and available in standard practice in that country.
    4. ECOG performance status 0-1.
    5. At least three weeks since the last therapy regimen prior to enrollment. Patients must have recovered to NCI CTCAE v3.0< or equal Grade 1 from all acute toxicities (excluding toxicities that are not considered a safety risk by the sponsor and investigator such as alopecia or residual peripheral neuropathy resulting from prior systemic therapy) or the toxicity must be deemed irreversible by the investigator.
    6. At least one week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
    7. Patients must have adequate hematologic, renal and liver function determined within 14 days prior to enrollment, defined as:
    a. Absolute neutrophil count > or equal 1.0 x 10e9 cells/L.
    b. Platelets > or equal 50 x 10e9/L.
    c. Hemoglobin > or equal 8 g/dL.
    d. Aspartate and alanine aminotransferases (AST, ALT) < or equal 5 x ULN (upper limit of normal).
    e. Total serum bilirubin < or equal 2 x ULN
    f. Serum creatinine < or equal 2.0 mg/dL.
    8. Negative pregnancy test within 72 hours of initial dose of CP-751,871 for females of child-bearing potential. Patients must be surgically sterile or postmenopausal females, or must agree to use double barrier contraception during the period of therapy and for 5 months following the last dose of the study drug. Double barrier contraception is defined as male condom plus spermicide in combination with a female condom, diaphragm, or cervical cap; or male condom plus spermicide in combination with an intrauterine device. Within these limits, the specific form of contraception employed is left to the discretion of the patient or the principal investigator.
    9. Evidence of a personally signed and dated informed consent indicating that the patient (or a legally acceptable representative) has been informed of all the pertinent aspects of the study.
    10. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
    E.4Principal exclusion criteria
    1. Concomitant treatment with other anti-cancer therapy.
    2. Prior anti IGF-IR based investigational therapy. Other investigational therapies (targeted or vaccine), unless otherwise agreed by investigators and sponsor, will require 4 weeks wash-out period or 5 half-lives of the agent, which ever is sooner, before enrollment.
    3. Symptomatic brain metastases. Brain metastases stable for <2 weeks before dosing or requiring concurrent steroid therapy or with clinical symptoms. Clinical symptoms suggestive of new brain metastasis within 2 weeks of enrollment. If such evidence exists, new brain metastasis must be ruled out by a CT scan or MRI. Patients that develop brain metastasis during the study will not need to have their treatment interrupted to receive a course of cranial radiation.
    4. Major surgery within 4 weeks prior to study enrollment or not fully recovered from side effects of previous procedures.
    5. Previous or current malignancies at sites other than basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrent disease for 12 months.
    6. Significant active cardiac disease including: uncontrolled high blood pressure (ie, systolic blood pressure >180 mm Hg, diastolic blood pressure >95 mm Hg), unstable angina, deep venous thrombosis, pulmonary embolism, cerebro vascular attack, valvular disease, congestive heart failure, myocardial infarction (within the previous 6 months), or serious cardiac arrhythmias.
    7. Patients who are receiving chronic high-dose systemic immunosuppressive steroid therapy (> or equal 100 mg prednisone per day or >40 mg dexamethasone per day). Use of high-dose corticosteroids within 2 weeks prior to enrollment.
    8. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
    9. Pregnancy or breast feeding.
    10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Six-month overall survival
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months25
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months25
    E.8.9.2In all countries concerned by the trial days0
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Please refer to sections 6.4 and 6.5 of the study protocol
    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 Decision2007-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-26
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