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    Summary
    EudraCT Number:2015-001605-14
    Sponsor's Protocol Code Number:CCR4309
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-07-17
    Trial 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 number2015-001605-14
    A.3Full title of the trial
    A Randomised, double-blind, placebo controlled, multi-centre phase II study to assess the Efficacy and safety of 2nd line Olaparib in combination with Paclitaxel, in Western patients with advanced gastric and gastro-oesophageal junction cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The OPERa study to assess the effectiveness and safety of Olaparib with Paclitaxel, in Western patients with advanced gastric and gastro-oesophageal junction cancer
    A.3.2Name or abbreviated title of the trial where available
    OPERa
    A.4.1Sponsor's protocol code numberCCR4309
    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 SponsorThe Royal Marsden NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationThe Royal Marsden NHS Foundation Trust
    B.5.2Functional name of contact pointMs Ye mong To
    B.5.3 Address:
    B.5.3.1Street AddressDowns Road
    B.5.3.2Town/ citySutton, Surrey
    B.5.3.3Post codeSM5 2PT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02086613807
    B.5.5Fax number02086613750
    B.5.6E-mailyemong.to@rmh.nhs.uk
    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 nameOlaparib (Lynparza)
    D.3.2Product code AZD2281
    D.3.4Pharmaceutical form Film-coated 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 INNolaparib
    D.3.9.1CAS number 763113220
    D.3.9.3Other descriptive nameLynparza
    D.3.9.4EV Substance CodeAS1
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Paclitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePaclitaxel (6 mg/ml concentrate for solution for infusion)
    D.3.2Product code L01CD01
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPaclitaxel
    D.3.9.1CAS number 33069624
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 nameOlaparib (Lynparza)
    D.3.2Product code AZD2281
    D.3.4Pharmaceutical form Film-coated 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 INNolaparib
    D.3.9.1CAS number 763113220
    D.3.9.3Other descriptive nameLynparza
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Gastric and Gastro-oesophageal cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of the stomach or lower oesophagus where it joins the stomach.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric 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 18.0
    E.1.2Level PT
    E.1.2Classification code 10062878
    E.1.2Term Gastrooesophageal 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 18.0
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric 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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10017760
    E.1.2Term Gastric cancer NOS
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10017768
    E.1.2Term Gastric cancer stage IV without metastases
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10066350
    E.1.2Term Adenocarcinoma of the gastrooesophageal junction
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10017761
    E.1.2Term Gastric cancer recurrent
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10017766
    E.1.2Term Gastric cancer stage IV NOS
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10061967
    E.1.2Term Gastric 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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10017767
    E.1.2Term Gastric cancer stage IV with metastases
    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
    Principal research question/Objective:

    To assess if adding olaparib to paclitaxel in the second line treatment of Western patients with advanced gastric cancer or oesophagi-gastric (OG) cancer improves overall survival, compared to treating patients with paclitaxel alone.

    Here overall survival is defined as the length of time from when a patient enters the study (and is assigned a treatment) to their death from any cause.
    E.2.2Secondary objectives of the trial
    Secondary Research Question/Objectives:

    • To investigate the safety and tolerability of the combination of olaparib and paclitaxel (i.e. which side effects are experienced by patients and the severity of these side effects)
    • To investigate the efficacy of olaparib in combination with paclitaxel compared with paclitaxel alone as defined by progression free survival (how long patients survive before their disease gets worse, progresses) and response rate (the proportion of patients who have a response to treatment with disease shrinkage on their CT scans)
    • To investigate the effect of treatment with olaparib in combination with paclitaxel compared with paclitaxel alone on patients' quality of life and symptoms, measured using questionnaires.
    • To investigate how commonly low levels of ATM protein are seen in advanced OG cancer in a Western population
    • To investigate the association of ATM levels with response to olaparib in a Western population
    • To investigate the efficacy o
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational sub-studies are planned. Full details to be confirmed at a later date.

    The study will include prospective tissue and blood collection, both at baseline, during treatment and at progression. One of the main aims of the translational sub-study is to identify possible factors in blood samples or tissue samples in advanced oesophagogastric cancer in Western patients, which may predict for sensitivity to PARP inhibition. We have a scientific collaboration planned and a full proposal is in development for later submission.
    E.3Principal inclusion criteria
    1. Advanced gastric or gastro-oesophageal junction cancer (HER2 positive or negative) which has progressed following first line treatment
    2. Male and female patients must be aged 18 or above*
    3. Availability of a tissue sample (resection or biopsy) confirming gastric or gastro-oesophageal junction adenocarcinoma*
    4. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI)
    5. Provision of fully informed consent*
    6. Adequate organ and bone marrow function measured within 28 days prior to starting treatment as detailed below:
    − Haemoglobin ≥ 10.0 g/dL and no blood transfusions in the 28 days prior to study entry
    − Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    − White blood cells (WBC) > 3 x 109/L
    − Platelet count ≥ 100 x 109/L
    − Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
    − AST/ ALT ≤ 2.5 x institutional ULN (unless liver metastases are present in which case it must be ≤ 5x ULN)
    − Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
    7. ECOG performance status of 2 or less
    8. Life Expectancy of 16 weeks or more
    9. Evidence of non-childbearing status for women of childbearing potential (ie negative urine or serum pregnancy test within 7 days of study treatment) or postmenopausal status.
    Postmenopausal status is defined as:
    − Amenorrheic for 1 year or more following cessation of exogenous hormonal
    treatments,
    − LH and FSH levels in the post menopausal range for women under 50,
    − radiation-induced oophorectomy with last menses >1 year ago,
    − chemotherapy-induced menopause with >1 year interval since last menses,
    − or surgical sterilisation (bilateral oophorectomy or hysterectomy).
    10. Patient is willing and able to comply with the protocol for the duration of the study including having examinations, undergoing treatment and attending scheduled visits (including follow up).
    11. Patients of child bearing potential and their partners, who are sexually active, must agree to the use of two highly effective forms of contraception throughout their participation in the study and for 3 months after last dose of study drug(s). For example condom with spermicide and oral contraceptive/hormonal therapy or condom with spermicide and placement of an intra-uterine device.

    * Starred inclusion criteria must be met for enrolment to the pre-screening part of the study
    E.4Principal exclusion criteria
    1. More than 1 prior chemotherapy regimen used for the treatment of advanced gastric cancer (except for adjuvant/neoadjuvant chemotherapy which is permitted except with a taxane- see below)
    2. Any previous treatment with a PARP inhibitor, including olaparib*
    3. Any second primary cancer (except adequately treated non-melanoma skin cancer, curatively treated cervical carcinoma-in-situ and curatively treated other solid tumours with no evidence of disease for 5 years or more)
    4. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons) or investigational product within 2 weeks from the last dose prior to starting treatment (or a longer period depending on the defined characteristics of the agents used). A stable dose of bisphosphonates is permitted for bone metastases before and during the study as long as they were started at least 4 weeks prior to starting treatment
    5. Clinically significant heart disease or myocardial infarction within the previous 12 months
    6. Interstitial pneumonia or symptomatic fibrosis of the lungs
    7. Active brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with known brain metastases are eligible if they have been treated and there is no evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. Patients can take a stable dose of corticosteroids before and during the study as long as these were started 4 or more weeks prior to treatment
    8. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any previous major surgery
    9. Pregnant and breastfeeding women
    10. Patients considered a poor medical risk due to a serious uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent.
    11. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication absorption
    12. Persistent toxicities (of CTCAE grade 2 or above) with the exception of alopecia, caused by previous cancer therapy.
    13. Immunocompromised patients e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy.
    14. Patients with known active hepatic disease (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
    15. Patients with intestinal obstruction or patients with CTCAE grade ≥ 3 upper GI bleeding within 4 weeks of study entry
    16. Any previous treatment with a taxane in the metastatic or recurrent setting. (A taxane may have been used in the neoadjuvant or adjuvant setting, as long as progression occurred more than 6 months following completion of treatment)*
    17. Patients receiving the CYP3A4 inhibitors azole antifungals, macrolide antibiotics and protease inhibitors.
    18. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)*
    19. Previous enrolment in the present study*
    20. Resting ECG with QTc of over 470msec on 2 or more time points within a 24hr period or a family history of long QT syndrome.
    21. Patients with myelodysplastic syndrome/acute myeloid leukaemia
    22. Patients with a blood transfusion within 1 month prior to study start.
    23. Patients with known hypersensitivity to paclitaxel or olaparib or any of the excipients of the products*
    24. Patients with uncontrolled seizures

    * Starred exclusion criteria must not be met for enrolment to the pre-screening part of the study
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS) defined as time from randomisation to date of death, patients alive at time of analysis will be censored at date of last follow-up
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS will be calculated from the time of randomisation to the date of death from any cause, patients alive at time of analysis will be censored at date of last follow-up.

    This analysis will be performed at the end of this trial (expected 4 years from the start of recruitment).
    E.5.2Secondary end point(s)
    •Progression free survival (PFS) defined as time from randomization to date of radiological progression or death from any cause. PFS will be be evaluated according to RECIST 1.1 criteria. Progression events will be determined by local investigator assessment. Patients alive and progression free at time of analysis will be censored at date of last follow-up.
    •Overall Survival (OS) in ATM negative patients.
    •Objective response rate (ORR) defined as the proportion of patients with a reduction in tumour burden (CR or PR according to RECIST 1.1 criteria). Response will be determined by local investigator assessment. Additional scans specifically to confirm responses will not be required in this study. Patients with no scan available will be excluded from the analysis unless they are known to have progressed or died prior to the scan (included as having disease progression).
    •Patient reported outcome (PRO). Health related quality of life (HRQoL) will be assessed using EORTC QLQ-C30 and STO22 questionnaires. Subscales will be defined as per the standard guidelines.
    •Adverse event (AE) assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
    •Time to response (TTR) defined as time from randomisation to objective tumour response (CR or PR according to RECIST 1.1 criteria).
    •Duration of response (DoR) defined as time from 1st documented tumour response to disease progression (CR or PR to PD according to RECIST 1.1 criteria). Patients alive and progression free at time of analysis will be censored at date of last follow-up.

    Exploratory and subgroup analyses
    •Biomarker analyses- including but not limited to the measurement of HRD factors such as ATM, BRCA-1, MDC-1 and PARP to correlate outcome with study therapy
    •There will also be a number of pre-planned sub group analyses of all of the above according to ATM, performance status (0,1 or 2), p53 status, platinum sensitivity in 1st line treatment and time to progression (TTP) on 1st line treatment, as defined by time from randomisation to objective tumour progression
    E.5.2.1Timepoint(s) of evaluation of this end point
    All of these analysis will be performed at the end of this trial (expected 4 years from the start of recruitment).
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 No
    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
    The ‘end of study’ for the purposes of the European Clinical Trials Directive will be defined as one year after the last patient has had their last active study treatment.

    Patient follow up will continue until death to evaluate the end points of the trial.

    The ‘end of trial notification’ will be submitted to the relevant regulatory authorities (e.g. UK MHRA) and ethics committees within 90 days by the sponsor.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 154
    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)
    After a participant has ended his or her participation in the trial they will be advised by their treating oncologist regarding any further treatment options available to them, if they are fit enough for 3rd line treament. There is no standard third line treatment so it is likely they would have palliative care or further experimental treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CRO
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-05-23
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