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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-005235-14
    Sponsor's Protocol Code Number:A7471028
    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:2009-05-22
    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 number2008-005235-14
    A.3Full title of the trial
    A RANDOMIZED PHASE 2 TRIAL OF PF 00299804 VERSUS ERLOTINIB FOR THE TREATMENT OF ADVANCED NON SMALL CELL LUNG CANCER AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
    A.4.1Sponsor's protocol code numberA7471028
    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
    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.3.1Product namePF-00299804
    D.3.2Product code PF-00299804
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1042385-75-0
    D.3.9.2Current sponsor codePF-00299804
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1042385-75-0
    D.3.9.2Current sponsor codePF-00299804
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 No
    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
    Non-Small cell Lung 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 10061873
    E.1.2Term Non-small cell lung 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 assess Progression Free Survival (PFS) in patients randomized to PF 00299804 and to erlotinib
    E.2.2Secondary objectives of the trial
    • To assess secondary measure of efficacy in each arm including Objective Response Rate (ORR), Duration of Response (DR) , and Overall Survival (OS);
    • To evaluate the safety and tolerability in each arm;
    •To explore Patient Reported Outcomes (PRO), including health related quality of life and disease/treatment related symptoms in each arm;
    •To explore KRAS and HER family mutation status in tissue and in circulating tumor DNA in blood;
    •To explore the pre and post treatment levels of shed proteins/receptors related to HER signaling (possibly to include EGFR and HER 2 receptor extracellular domain [ECD] and E cadherin);
    •To explore EGFR mutations, including T790M, in blood at baseline and at end of study;
    •To collect sparse pharmacokinetic (PK) data for population meta analysis (popPK) at selected sites
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SAMPLES FOR PFIZER’S EXPLORATORY RESEARCH BIOBANK
    A RANDOMIZED PHASE 2 TRIAL OF PF-00299804 VERSUS ERLOTINIB FOR
    THE TREATMENT OF ADVANCED NON-SMALL CELL LUNG CANCER AFTER
    FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN:
    version date 22 July 2008
    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.
    For example, the biopsy samples may be used for investigations of the expression,
    amplification, or mutation of genes involved in HER signal transduction, as well as other
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Provision of a personally signed and dated voluntary written informed consent
    document;
    2. Age >/=18 years, male or female;
    3. Evidence of histologically confirmed, advanced NSCLC;
    a. For the purpose of randomization/ stratification the histologic subtype of NSCLC must be documented, preferably by WHO criteria
    b. The diagnosis of NSCLC NOS (not otherwise specified) will not be sufficient for enrollment and randomization/stratification.
    4. In general, specimen from diagnostic or recently obtained tumor tissue is to be sent to the Sponsor-designated central laboratory for KRAS mutation testing. Patients who have had KRAS testing previously at a sponsor approved laboratory are allowed to enroll if they meet all other eligibility criteria, and if tissue is sent from the site to the Sponsor designated central lab for independent confirmation of the KRAS test result:
    a. for KRAS testing, the availability of paraffin block or unstained slides is preferred, but fine needle aspirate material can also be accepted.
    b. For patients who have prior KRAS testing, a specimen for exploratory analysis of circulating tumor KRAS DNA in blood is still required, as per the trial objectives and endpoints.
    5. ECOG 0-2 performance status;
    6. Evidence of progressive disease after at least one and no more than two prior chemotherapy regimens for advanced disease; patients who completed prior adjuvant or combined modality therapy for regional disease within 12 months may be enrolled if they have received only one chemotherapy regimen for advanced disease:
    a. For the purpose of this study, chemotherapy regimen is defined as any chemotherapeutic agent(s) accepted as standard of care. In addition, prior investigational therapy will be counted as one regimen of systemic therapy, and such patients can therefore only be enrolled if they have received only one regimen of standard chemotherapy. Patients who have received investigational therapy as the only prior treatment for advanced NSCLC may not be enrolled.
    7. Any prior treatment (chemotherapy, radiation or surgery) must have been completed at least 2 weeks prior to randomization. Any acute toxicity must have been recovered to Grade 1 (per NCI CTCAE v3.0.1) or baseline;
    8. Measurable disease by RECIST criteria: a. At least one target lesion, that has not previously been radiated, measurable in at least one dimension of greater than 2 cm by conventional CT or MRI, or at least 10 mm by spiral CT, must be present;
    b. Palpable disease which is biopsy proven to be metastatic NSCLC (eg, skin nodule or lymphadenopathy), superficial, and measurable by caliper is allowed, though confirmation of measurement by CT or ultrasound is encouraged;
    c. Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral CT, or MRI; contrast enhanced scans are required
    in the absence of contrast-allergy and patient intolerance of MRI.
    9. Brain metastasis treated with radiation or surgery allowed if radiologically and neurologically stable off corticosteroids at least 2 weeks prior to randomization;
    10. Adequate Bone Marrow Function, including:
    a. Absolute neutrophil count (ANC) >/= 1000 cells/mm3;
    b. Platelets >/= 100,000 cells/mm3.
    11. Adequate Renal Function, including:
    a. Estimated creatinine clearance >/= 60 mL/min;
    b. Serum creatinine <1.5 x ULN (upper limit of normal);
    c. No known history of renal papillary necrosis or pyelonephritis.
    12. Adequate Liver Function, including:
    a. Bilirubin </= 1.5 x ULN;
    b. AST (SGOT) </= 2.5 x ULN (</= 5.0 x ULN if hepatic metastases);
    c. ALT (SGPT) </= 2.5 x ULN (</= 5.0 x ULN if hepatic metastases).
    13. Female patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. (The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Where advised by investigator, double barrier contraception is defined as condom plus spermicide in combination with a female condom, diaphragm, cervical cap or intrauterine device);
    14. All female patients with reproductive potential must have a negative pregnancy test
    (serum/urine) within 72 hours prior to starting treatment;
    15. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter.
    16. Patients who are willing and able to comply with scheduled visits, treatment plan,
    laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the trial.
    1. Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer;
    2. Patients with known leptomeningeal metastases, or symptomatic brain metastases. (Screening CNS imaging in asymptomatic patients is not a required trial procedure.) Patients with previously diagnosed brain metastases for which treatment (radiation or surgery) is recommended in the judgment of investigator are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable;
    3. Chemotherapy, radiotherapy (other than palliative radiotherapy to lesions that will not be followed for tumor assessment on this study, ie, non target lesions), biological or investigational agents within 2 weeks of baseline disease assessments;
    4. Prior therapy with an agent that is known or proposed to be active by action on: EGFR tyrosine kinase or other HER family proteins including but not limited to erlotinib (Tarceva®), gefitinib (Iressa®), lapatinib (Tykerb®), cetuximab (Erbitux®), panitumumab (Vectibix®), trastuzumab (Herceptin®), ZD6474 (Zactima®), cantertinib (CI-1033), HKI-272, BIBW-2992, XL-647, AEE788, matuzumab, and pertuzumab;
    5. Any surgery (not including minor procedures such as lymph node biopsy) within 4 weeks of baseline disease assessments; or not fully recovered from any side effects of previous procedures;
    6. Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug, such as the inability to take oral medication in tablet form;
    7. Current enrollment in another therapeutic clinical trial;
    8. Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol;
    9. Patients with known interstitial lung disease
    10. Uncontrolled or significant cardiovascular disease, including:
    a. Myocardial infarction within 12 months;
    b. Uncontrolled angina within 6 months;
    c. Congestive heart failure within 6 months or left ventricular ejection fraction below local institutional lower limit of normal or below 50%;
    d. Diagnosed or suspected congenital long QT syndrome;
    e. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
    f. Prolonged QTc interval on pre entry electrocardiogram. QTc must be of less than CTC Grade 2 (≤470 msec) using appropriate correction formula with manual read by investigator if required. The ECG may be repeated for evaluation of eligibility after management of correctable causes for observed QTc prolongation;
    g. Any history of second or third degree heart block (may be eligible if currently have a pacemaker);
    h. Heart rate <50/minute on baseline electrocardiogram;
    i. Uncontrolled hypertension.
    11. Prior malignancy: Patients will not be eligible if they have evidence of other malignancy (other than non melanoma skin cancer or in situ cervical cancer, or localized and presumed cured prostate cancer with PSA < ULN) within the last 3 years.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free 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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    erlotinib
    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 concerned5
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 160
    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 Decision2008-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-08
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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