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    Summary
    EudraCT Number:2009-012097-12
    Sponsor's Protocol Code Number:TP103EU
    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:2009-07-06
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-012097-12
    A.3Full title of the trial
    Phase II, open-label, multi-centre study of TP300 as a single agent as first line therapy in patients with advanced gastric cancer or gastroeosophageal junction adenocarcinoma.
    A.3.2Name or abbreviated title of the trial where available
    TP103EU
    A.4.1Sponsor's protocol code numberTP103EU
    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 SponsorCHUGAI PHARMA EUROPE LIMITED
    B.1.3.4CountryUnited Kingdom
    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 nameTP300
    D.3.2Product code CH4556300-003
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTP103 EU
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Patients with advanced gastric cancer or gastroeosophageal junction (Types II & III) adenocarcinoma will be investigated. Patients will be given TP300 as a single agent as first line therapy administered every 3 weeks.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10001141
    E.1.2Term Adenocarcinoma
    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 the objective response (OR), defined as complete or partial response (CR/PR), assessed in accordance with the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
    E.2.2Secondary objectives of the trial
    1. To assess progression-free survival (PFS), which is defined as being dated from the time of first dose until the date of disease progression or death whichever occurs first.

    2. To assess the time to progression (TTP), defined as the time from first dose to first progression of disease.

    3. To assess the safety and tolerability of TP300.

    4. To further assess pharmacokinetic (PK) characteristics of TP300 active form and active metabolite.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient can be included in the study only if they meet all of the following criteria:
    1. Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma (Siewart type II or III).
    2. Male or female aged ≥ 18 years.
    3. ECOG performance status of 0 or 1.
    4. Life expectancy of ³ 3 months.
    5. Disease measurability, which can be assessed using the RECIST 1.1 criteria.
    6. Adequate bone marrow function as defined by: absolute neutrophil count (ANC) of ³ 1.0 109/L, platelet count of ³ 100 109/L, and haemoglobin of ³ 9 g/dL.
    7. Adequate liver function, as determined by:
    • Serum total bilirubin £ 1.5 (upper limit of normal [ULN]), aspartate amino transferase (AST) and alanine amino transferase (ALT) £ 2.5 ULN (£ 5 ULN if liver metastases); alkaline phosphatase (ALP) < 2.5 ULN (< 5 ULN if liver metastases).
    • Normal albumin.
    • There is no upper limit for ALP if elevation is due to bone metastases.
    8. Adequate renal function shown by serum creatinine ≤ 1.5 ULN.
    9. Signed informed consent.
    10. Ability to comply with protocol requirements (visits and assessment schedules) and willingness to allow blood sampling.
    11. Females must be post-menopausal (12 months of amenorrhea), surgically sterile, or must agree to use a physical method of contraception. Oral or injectable contraceptive agents cannot be the sole method of contraception.
    12. Male patients must be surgically sterile or agree to use a barrier method of contraception.
    13. Female patients of child bearing potential must have a negative urine pregnancy test within the 7 days before study drug administration.
    E.4Principal exclusion criteria
    Patients will be excluded from the study for any of the following reasons:
    1. Patients with known (past or present) central nervous system (CNS) metastases.
    2. Prior chemotherapy, radiotherapy (other than local palliative radiotherapy for bone pain), or immunotherapy within 28 days of first receiving study drug.
    3. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months before study treatment.
    4. Prior toxicities from chemotherapy or radiotherapy that have not regressed to Grade £1 severity (NCI CTCAE version 3.0).
    5. Prior corticosteroids as anti-cancer therapy within a minimum of 21 days of first receiving study drug.
    6. No prior chemotherapy for (advanced, metastatic, or recurrent) gastric or gastro-oesophageal adenocarcinoma is allowed. Patients are allowed to have received prior neoadjuvant or adjuvant chemotherapy/chemo-radiation but at least 12 months should have elapsed since completion of neoadjuvant or adjuvant therapy.
    7. Treatment with any investigational agent within 28 days of first receiving study drug.
    8. Patients with active or uncontrolled infection. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, contraindicates the use of an investigational drug, or will impose excessive risk to the patient. Examples of such medical conditions include significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina pectoris) or severe obstructive pulmonary disease.
    9. Major surgery within 28 days of first receiving study drug.
    10. Pregnant or lactating women.
    11. Altered mental status or psychiatric disorder that in the opinion of the investigator would preclude a valid patient informed consent.
    12. Previous history of malignancy in the last 5 years except carcinoma in situ of the cervix or basal cell carcinoma of the skin.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:

    The primary endpoint will be objective response, defined as CR or PR, assessed in gastric cancer in accordance with the RECIST 1.1 criteria in solid tumours. Patients will have a computerised tomography (CT) scan after 2 cycles of treatment. The same radiographic procedure used at baseline must be used through the study.
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    TP300 is a single agent to be used in first line therapy in patients.
    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 concerned6
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    This definition is provided in the protocol.
    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 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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-07-06. Yes
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 43
    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)
    This has already been provided in the protocol.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-22
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