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    Summary
    EudraCT Number:2013-002620-17
    Sponsor's Protocol Code Number:B7461001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2014-06-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-002620-17
    A.3Full title of the trial
    Phase 1/2 study of PF-06463922 (an ALK/ROS1 tyrosine kinase inhibitor) in patients with advanced non-small cell lung cancer harboring specific molecular alterations.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with investigational drug PF-06463922 in patients with a specific type of advanced lung cancer
    A.4.1Sponsor's protocol code numberB7461001
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportPfizer Inc, 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York, NY
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.com
    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-06463922
    D.3.2Product code PF-06463922
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06463922
    D.3.9.3Other descriptive namePF-06463922 Form 3 (acetic acid solvate)
    D.3.9.4EV Substance CodeSUB126819
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    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-06463922
    D.3.2Product code PF-06463922
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06463922
    D.3.9.3Other descriptive namePF-06463922 Form 3 (acetic acid solvate)
    D.3.9.4EV Substance CodeSUB126819
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 3
    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-06463922
    D.3.2Product code PF-06463922
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06463922
    D.3.9.3Other descriptive namePF-06463922 Form 3 (acetic acid solvate)
    D.3.9.4EV Substance CodeSUB126819
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Anaplastic Lymphoma Kinase (ALK)-positive (ALK+) or ROS oncogene 1 (ROS1)-positive (ROS1+) advanced non-small cell lung cancer (NSCLC).
    E.1.1.1Medical condition in easily understood language
    a specific type of advanced lung cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10066490
    E.1.2Term Progression of non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study has separate primary objectives for the two study portions: Phase 1 and Phase 2.
    Phase 1 study portion:
    To assess safety and tolerability of PF-06463922 as a single agent at increasing dose levels in patients with advanced ALK+ or advanced ROS1+ NSCLC in order to estimate the Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).
    Phase 2 study portion:
    To evaluate overall (intra- and extra-cranial) and intracranial anti-tumor activity of single-agent PF-06463922 at RP2D in patients with advanced ALK+ NSCLC and advanced ROS1+ NSCLC.
    E.2.2Secondary objectives of the trial
    Please refer to study protocol to check separate secondary objectives for the two study portions Phase 1 and Phase 2.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - During the Phase 1 portion of the study, a midazolam (MDZ) drug-drug interaction (DDI) substudy will be conducted at 3 to 4 PF-06463922 dose levels to evaluate the effect of PF-06463922 on CYP3A inhibition/ induction.
    - During the Phase 2 portion of the study, a MDZ DDI substudy and a food effect substudy will be conducted at the Recommended Phase 2 Dose (RP2D) in advanced ALK+ NSCLC patients.
    E.3Principal inclusion criteria
    1. Evidence of histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved FISH assay (Abbott Molecular Inc) or by Immunohistochemistry (IHC) (Ventana Inc), or a ROS1 rearrangement as determined by FISH or RT-PCR or Next Generation Sequencing (NGS) via a local diagnostic test (LDT). A central laboratory confirmation by a Sponsor-selected, validated test will retrospectively determine final ROS1 status. All patients (ALK positive and ROS1 positive) must have archival tissue sample available and collected prior to enrollment.
    2. Disease Status Requirements
    Phase 1: ALK+ positive NSCLC patients must either be treatment naïve in the advanced setting or have had disease progression after 1 or 2 previous ALK inhibitor therapy(ies). ROS1+positive NSCLC patients must either be treatment naïve in the advanced setting or have had disease progression after 1 or 2 previous ROS1 inhibitor therapy(ies).
    Phase 2: ALK positive NSCLC patients must either be treatment naïve in the advanced setting or have had disease progression after 1 or 2 previous ALK inhibitor therapy(ies) as the last therapy given. ROS1 positive NSCLC patients must either be treatment naïve in the advanced setting or have had disease
    progression after 1 or 2 previous ROS1 inhibitor therapy(ies) as the last therapy given.
    3. Tumor Requirements:
    Phase 1: All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) will be eligible. The brain metastases may be newly diagnosed or be present as progressive disease after surgery, whole brain radiotherapy or stereotactic radiosurgery (see Exclusion Criterion #3 for the lapsed time period required between the end of radiotherapy and study entry). Patients who have asymptomatic radiologically suspected leptomeningeal disease (LM) or carcinomatous meningitis (CM) and negative spinal fluid (CSF) are eligible to enter Phase 1.
    Phase 2: All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible. The brain metastases may be newly diagnosed or be present as progressive disease after surgery, whole brain radiotherapy or stereotactic radiosurgery (see Exclusion Criterion #3 for the lapsed time period required between the end of radiotherapy and study entry). Patients who have leptomeningeal disease (LM) or carcinomatous meningitis (CM) will be eligible if the LM/CM is visualized on MRI or if documented baseline cerebral spinal fluid (CSF) positive cytology is available.
    4. Age >=18 years.
    5. ECOG Performance Status (PS):
    - Phase 1: 0 or 1;
    - Phase 2: 0, 1, or 2.
    6. Adequate Bone Marrow Function, including:
    - Absolute Neutrophil Count (ANC) >=1.5 x 109/L;
    - Platelets >=100 x 109/L;
    - Hemoglobin >=9 g/dL.
    7. Adequate Pancreatic Function, including:
    - Serum total amylase within normal limits per local laboratory ranges. If not within normal limits, then pancreatic isoenzyme must be <1.5 ULN.
    - Serum lipase <=1.5 ULN.
    8. Adequate Renal Function, including:
    - Serum creatinine <=1.5 x ULN or estimated creatinine clearance >=60 mL/min as calculated using the method standard for the institution.
    9. Adequate Liver Function, including:
    - Total serum bilirubin <=1.5 x ULN;
    - Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) <=2.5 x ULN; <=5.0 x ULN if there is liver metastases involvement;
    - Alkaline phosphatase <=2.5 x ULN (<=5 x ULN in case of bone metastasis).
    10. Acute effects of any prior therapy resolved to baseline severity or to CTCAE Grade <=1 except for AEs that in the investigator' judgment do not constitute a safety risk for the patient.
    11. Serum pregnancy test (for females of childbearing potential) negative at screening and at the baseline visit (before the patient may receive the investigational product). A patient is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
    12. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
    13. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

    For more inclusion criteria refer to the protocol.
    E.4Principal exclusion criteria
    1.Spinal cord compression is excluded unless the patient demonstrates good pain control attained through therapy and there is stabilization or recovery of neurological function for the 4 weeks prior to study entry
    2.Major surgery within 4 weeks of study entry.Minor surgical procedures are not excluded but sufficient time should have passed for wound healing
    3.Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry.Palliative radiation (<=10 fractions) must have been completed at least 48 hours prior to study entry.Stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry.Whole brain radiation must have completed at least 4 weeks prior to study entry
    4.Systemic anti-cancer therapy completed within a minimum of 5 half lives of study entry
    5.Previous high-dose chemotherapy requiring stem cell rescue
    6.Prior irradiation to >25% of the bone marrow
    7.Active and clinically significant bacterial, fungal, or viral infection including HBV, HCV, known HIV or AIDS-related illness
    8.Any one of the following currently or in the previous 3 months: myocardial infarction,congenital long QT syndrome,Torsades de Pointes,arrhythmias,right bundle branch block and left anterior hemiblock (bifascicular block),unstable angina,coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident,transient ischemic attack or symptomatic pulmonary embolism not adequately medically managed with anticoagulants;as well as bradycardia defined as <50 bpms.Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2,symptomatic atrial fibrillation of any grade,or QTc interval <=481 msec at screening.Right bundle branch block
    9.Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (see protocol for more details).
    10.History of extensive,disseminated,bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersentivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis. Patients with history of prior radiation pneumonitis are not excluded
    11.Participation in other NSCLC treatment studies (i.e. date of last treatment dose) within 2 weeks prior to study entry
    12.Other severe acute or chronic medical or psychiatric condition,including recent (within the past year) or active suicidal ideation or behavior,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 patient inappropriate for entry into this study
    13.Patients who are investigational site staff members directly involved in the conduct of the trial and their family members,site staff members otherwise supervised by the Investigator,or patients who are Pfizer employees directly involved in the conduct of the trial
    14.Evidence of active malignancy within the last 3 years. See protocol for more details
    15.Active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease or previous gastric resection or lap band. Gastroesophageal reflux disease under treatment with proton-pump inhibitors is allowed

    For more exclusion criteria refer to the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 Primary Endpoint:
    - Cycle 1 Dose-Limiting Toxicities (DLTs).
    Phase 2 Primary Endpoint:
    - Objective tumor response, as assessed by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. In patients with asymptomatic CNS metastases, up to five (5) intracranial target lesions in addition to the five (5) extracranial target lesions will be assessed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1 Primary Endpoint:
    - Cycle 1 Dose-Limiting Toxicities (DLTs): cycle 1.
    Phase 2 Primary Endpoint:
    - Objective tumor response: at baseline and at the stipulated intervals during treatment.
    Please refer to Schedule of Activities of the protocol.
    E.5.2Secondary end point(s)
    Secondary Endpoints [all patients unless otherwise indicated]:
    - MTD and RP2D [Phase 1 only].
    - Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03), seriousness and relationship to study therapy.
    - Laboratory abnormalities as characterized by type, frequency and severity (as graded by NCI CTCAE v.4.03).
    - Left Ventricular Ejection Fraction (LVEF).
    - Vital Signs (heart rate, blood pressure).
    - Total Mini Mental State Examination Score.
    - Pharmacokinetic parameters of PF-06463922: Single Dose - Cmax, Tmax, AUClast,AUC t, CL/F, and Vz/F and t1/2, AUCinf as data permit. Multiple Dose (assuming steady-state is achieved) - Css,max, Tss,max, AUCss,t, t1/2, Css,min, Css,av, CL/F, Vss/F, Rac (AUCss,t/AUCsd,t) and Rss (AUCss,t/AUCsd,inf) as data permit. Urine PK parameters (Ae%, and CLR) of PF-06463922 from MDZ and food effect substudy.
    - Pharmacokinetic parameters of midazolam: Cmax, Tmax, AUClast, CL/F, and Vz/F and t1/2, AUCinf as data permit.
    - Patient reported functioning and impact on disease/treatment-related symptoms of lung cancer and global QOL.
    - QTc interval.
    - Disease Control Rate (DCR) at 12 weeks defined as the percent of patients with a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1 at 12 weeks.
    - Objective tumor response, as assessed by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 (Appendix 3) [Phase 2 only]. In patients with asymptomatic CNS metastases, up to 5 intracranial target lesions in addition to the 5 extracranial target lesions will be assessed.
    - Time-to-event endpoints: eg, Progression-Free Survival (PFS), Overall Survival (OS) at 1 year and 18 months, Duration of Response (DR), and Time to Tumor Response (TTR).
    - Time to Progression (TTP), Time to Intracranial Progression (IC-TTP) and Time to Extracranial Progression (EC-TTP) [Phase 2 only]
    - CTC enumeration and molecular characterization.
    - Selected molecular profiling of tumor tissue, eg, ALK kinase domain mutations.
    - Selected molecular profiling of Circulating Nucleic Acid (CNA), eg, ALK kinase domain mutations.
    - CSF concentration of PF-06463922.
    Phase 1 Exploratory Endpoints:
    - Time to Progression (TTP), Time to Intracranial Progression (IC-TTP) and Time to Extracranial Progression (EC-TTP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to Schedule of Activities of the protocol.
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To characterize the effect of food on single-agent PF-06463922 at the RP2D (ALK+NSCLC patients only) in the Phase 2 Portion of the Study.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA22
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Korea, Republic of
    Singapore
    Spain
    Switzerland
    Taiwan
    United Kingdom
    United States
    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
    In a Member State of the European Union: time at which it is deemed that sufficient patients have been recruited and completed the study as stated in the regulatory and ethics applications (ie, CTA) in the Member State. Poor recruitment by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.
    End of Trial in all other participating countries: 18 months after Last Patient First Visit (LPFV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 200
    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)
    Patients may continue PF-06463922 treatment after objective progression of disease is determined if the patient is continuing to experience clinical benefit, in the opinion of the investigator, and after discussion with the Sponsor.
    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 Decision2014-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-18
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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