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    Summary
    EudraCT Number:2018-000454-22
    Sponsor's Protocol Code Number:CCR4825
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-11-21
    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 number2018-000454-22
    A.3Full title of the trial
    A translational phase II study of single agent Olaparib in the treatment of advanced oesophagogastric cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SOlar
    A.3.2Name or abbreviated title of the trial where available
    SOlar
    A.4.1Sponsor's protocol code numberCCR4825
    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 pointClaire Saffery
    B.5.3 Address:
    B.5.3.1Street AddressDowns Road
    B.5.3.2Town/ citySutton, Surrey
    B.5.3.3Post codeSM2 5PT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02086613637
    B.5.6E-mailclaire.saffery@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 100mg
    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 INNOlaparib 100mg
    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 number300
    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 nameOlaparib 150mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Oesophago-gastric cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the anti-tumour activity of olaparib in advanced oesophageal, gastro-oesophageal junction and gastric cancer.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of olaparib.
    - To assess further efficacy measures; objective response rate, duration of response, overall survival, progression free survival and time to radiological progression
    - To perform translational research analysis that may identify predictive biomarkers for future therapies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Locally advanced or metastatic oesophageal, gastro-oesophageal junction or gastric adenocarcinoma that has progressed during or within 6 months of first or subsequent line treatment
    • Patients with HER2-positive oesophageal, gastro-oesophageal, or gastric adenocarcinoma must have received previous treatment with trastuzumab
    • Male and female patients ≥18 years of age
    • Availability of tissue sample (resection or biopsy) confirming oesophageal, gastro-oesophageal junction, or gastric adenocarcinoma. If the patient does not have prior histological diagnosis, then the planned baseline fresh tumour biopsy may be used for both the purpose of confirming the histological diagnosis and subsequent biomarker analysis. All patients must be willing to have a fresh tumour biopsy to obtain tumour tissue for biomarker analysis at baseline and on progression
    • Disease amenable to safe biopsy
    • At least one lesion, not previously irradiated, that can be accurately measured as per RECIST criteria 1.1
    • Able to give informed consent
    • Adequate organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
    • Hb 10.0 g/dL independent of blood transfusions for 28 days
    • Absolute neutrophil count (ANC)  1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • INR < 1.5
    • 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)
    • Creatinine clearance >51 mL/min for patients with creatinine levels above institutional normal.
    • Albumin >33 g/L
    • WHO ECOG performance status 0-1
    • Life expectancy of 16 weeks or more
    • Evidence of non-childbearing potential (i.e. negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1) or postmenopausal status
    • 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)
    • Patients of child bearing potential and their partners, who are sexually active, must agree to the use of TWO highly effective forms of contraception in combination throughout their participation in the study and for at least 1 month after the last dose of study drug. For example, condom with spermicide and oral contraceptive/hormonal therapy or condom with spermicide and placement of an intra-uterine device. (See Appendix A for acceptable forms of contraception)
    E.4Principal exclusion criteria
    • Any previous treatment with a PARP inhibitor, including olaparib
    • 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)
    • Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons) or investigational product within 4 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
    • Clinically significant heart disease such as uncontrolled symptomatic arrhythmias, congestive heart failure, or myocardial infarction within the previous 3 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
    • Interstitial pneumonia or symptomatic fibrosis of the lungs
    • Active brain or leptomeningeal metastases
    • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any previous major surgery
    • Pregnant and breastfeeding women
    • Patients considered a poor medical risk due to a serious uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection.
    • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication absorption
    • Persistent toxicities (of CTCAE grade 2 or above) with the exception of alopecia, caused by previous cancer therapy
    • Immunocompromised patients e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV)
    • Patients with known active hepatic disease (i.e. Hepatitis B or C)
    • Patients with intestinal obstruction or patients with CTCAE grade ≥ 3 upper GI bleeding within 4 weeks of study entry
    • Concomitant use of known strong or moderate CYP3A inhibitors. The required washout period prior to starting olaparib is 2 weeks. (See Section 11.6.5 regarding the use of CYP3A inhibitors).
    • Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents (See Section 12.6.5 regarding the use of CYP3A inducers)
    • Resting ECG with QTc of over 500 msec on 2 or more time points within a 24 hour period or a family history of long QT syndrome.
    • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or features suggestive of MDS/AML
    • Patients with known hypersensitivity to olaparib or any of the excipients of the products
    • Vaccinated with live, attenuated vaccines within 4 weeks of enrolment
    • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is disease control rate (DCR) defined as stable disease, partial response or complete response according to RECIST 1.1 criteria 8 weeks from initiation of study drug
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks from initiation of study drug
    E.5.2Secondary end point(s)
    • Objective response rate (ORR) will be defined in the EvP as complete response or partial response at 8 weeks according to RECIST 1.1. The objective response rate will be presented along with its exact two-sided 95% confidence interval.
    • Time to radiological progression (TTP) will be defined in the EvP as time from initiation of study drug to radiological tumour progression (PD according to RECIST 1.1 criteria). Death from cancer or any other cause without prior radiological evidence of progression will not count as an event. If no event exists, then time to radiological progression will be censored at the last scheduled disease assessment on study or date of death whichever occurs earlier.
    • Progression free survival (PFS) will be defined in the ITT population as time from initiation of study drug until radiological progression, unequivocal clinical progression or death. If no event exists, then PFS will be censored at the last scheduled disease assessment on study.
    • Overall survival (OS) will be defined in the ITT population as time from initiation of study drug to date of death. Survival time of living patients will be censored on the last date a patient is known to be alive or lost to follow-up.

    Duration of response (DoR) defined in the EvP as time from 1st documented tumour response (CR or PR, RECIST 1.1) to disease progression (PD, RECIST 1.1). Responding patients alive and progression free at time of analysis will be censored at date of last follow-up.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For TTP, PFS, OS, and DoR, median survival and fixed time point (at 6m, 12m) survival rates will be estimated using the Kaplan-Meier method, and survival curves will be generated. As a sensitivity analysis we will re-analyse DCR, ORR, TTP and DoR on the PP population.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States No
    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 Yes
    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 study end date is deemed to be the date of last data capture. Patient follow up will continue until death to evaluate the survival endpoint of the trial.
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    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)
    Trial participants will receive olaparib until radiological progression assessed by RECIST 1.1 criteria on CT imaging. Patients will be advised by their treating oncologist if further treatment is necessary and what these treatments could be.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-01
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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