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    Summary
    EudraCT Number:2009-010730-21
    Sponsor's Protocol Code Number:TEL0805
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-04-21
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-010730-21
    A.3Full title of the trial
    A Phase 2 Open-Label Study Evaluating the Efficacy and Safety of Telatinib in Combination with Chemotherapy as First-line Therapy in Subjects with Advanced Gastric Cancer

    Estudio de fase 2, abierto, de evaluación de la eficacia y la seguridad de telatinib en combinación con quimioterapia como tratamiento de primera línea en pacientes con cáncer gástrico avanzado
    A.4.1Sponsor's protocol code numberTEL0805
    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 SponsorACT BIOTECH, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTelatinib
    D.3.2Product code ACTB 1001-b
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTelatinib
    D.3.9.1CAS number 75747-14-7
    D.3.9.2Current sponsor codeACTB 1001-b
    D.3.9.3Other descriptive nameTelatinib mesylate; formerly known as BAY 60-8524
    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) 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.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 Information not present in EudraCT
    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 nameCapecitabine
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAPECITABINE
    D.3.9.1CAS number 154361-50-9
    D.3.9.3Other descriptive nameCAPECITABINA
    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) 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.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 Information not present in EudraCT
    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 nameCisplatin
    D.3.4Pharmaceutical form Concentrate for solution for 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.3.8INN - Proposed INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Patient population includes patients with Advance gastric cancer, with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Patients must have measurable disease and must not have received prior systemic anticancer therapy for advance or metastatic gastric cancer.

    Indicación: Cáncer Gastrico Avanzado
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level PT
    E.1.2Classification code 10061967
    E.1.2Term Gastric cancer stage IV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Progression-free survival (PFS)
    E.2.2Secondary objectives of the trial
    Overall survival (OS)
    Overall response rate (ORR)
    Safety and tolerability
    Pharmacokinetics and biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age > 18 years
    2. Histologically or cytologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy
    3. At least 1 measurable lesion that has not been irradiated. The lesion will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST), and be documented by radiological evaluation within 28 days prior to study entry
    (4. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at study entry
    5. Prior radiation therapy completed at least 28 days prior to study entry (if applicable)
    6. Adequate bone marrow, liver, and renal function at study entry as assessed by:
    • Hemoglobin > 9.0 g/dL (transfusion and growth factor independent)
    • Platelet count > 100,000/µL (transfusion independent)
    • Absolute neutrophil count (ANC) > 1500/µL (growth
    factor independent)
    • Total bilirubin < 2.0 times the upper limit of normal
    (ULN)
    • Alanine aminotransferase (ALT [SGPT]) and aspartate aminotransferase (AST [SGOT]) < 5.0 x ULN in the presence of liver metastasis; ALT [SGPT] and AST [SGOT] < 2.5 x ULN in the absence of liver
    metastasis
    • International normalized ratio for prothrombin time
    (PT-INR) < 1.5 and activated partial thromboplastin
    time (aPTT) < 1.5 x ULN. The use of full-dose oral or
    parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the subject has been on a stable dose of anticoagulants for at least two weeks before study entry.
    • Serum creatinine < 1.5 times ULN
    • Calculated creatinine clearance > 60 mL/min. The
    Cockroft and Gault formula (Section 12.7) is
    recommended for calculation of creatinine clearance.
    Subjects with a calculated creatinine clearance below 60 mL/min may be eligible if a measured creatinine
    clearance (based on 24 hour urine collection or other
    reliable method) is > 60 mL/min
    7. Negative serum pregnancy test performed within 7 days prior to study entry for women of childbearing potential
    8. Women and men of childbearing potential must agree to use adequate contraception (e.g., condom, intrauterine device (IUD), oral contraceptive, or double-barrier method), prior to study entry, for the duration of study participation and 28 days
    after the last study drug dosing
    9. Able and willing to sign a written informed consent. A signed informed consent must be appropriately obtained prior to any study specific procedures.
    10. Able to comply with study procedures and follow-up examinations
    E.4Principal exclusion criteria
    1. Previous chemotherapy for locally advanced or metastatic gastric cancer. Subjects may have received prior neoadjuvant or adjuvant chemotherapy as long as it was completed at least
    6 months prior to study entry.
    2. Previous anti-angiogenic therapy (i.e. anti-VEGF or VEGFR tyrosine kinase inhibitor such as bevacizumab, sorafenib,sunitinib, AZD2171)
    3. Previous total platinum dose >300 mg/m2 [Total prior platinum dose of <300 mg/m2 will be allowed in the adjuvant or neo-adjuvant setting as long as it was completed at least 6 months prior to study entry]
    4. Locally advanced disease that is amenable to curative therapy (including operation and/or chemotherapy and/or radiotherapy)
    5. Clinical or radiographic evidence of brain metastasis
    6. Cardiac disease defined by:
    • Congestive heart failure > class II New York Heart
    Association (NYHA) (Section 12.5), or
    • Unstable angina (anginal symptoms at rest), or newonset angina (began within the last 12 months), or myocardial infarction within the 12 months prior to
    enrolment, or
    • Cardiac ventricular arrhythmias requiring antiarrhythmic therapy
    • Atrial fibrillation or atrioventricular heart block
    7. Uncontrolled hypertension at study entry (systolic blood pressure >150 mmHg or diastolic pressure > 90 mmHg) despite optimal medical management
    8. Any (including pulmonary) hemorrhage/bleeding event > grade 3 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.3.0 within 28 days prior to study entry
    9. Major surgery, open biopsy, or significant traumatic injury within 28 days prior to study entry
    10. Current serious, non-healing wound, ulcer, or bone fracture at study entry
    11. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry
    12. Active clinically serious infection > grade 3 by NCI-CTCAE v.3.0 at study entry
    13. Known human immunodeficiency virus (HIV) infection or chronic hepatitis B (HBV) or C (HCV). The safety of telatinib in this subject population has not been studied.
    14. Previous or concurrent cancer that is distinct in primary site or histology from gastric cancer. Subjects with cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated > 3 years
    prior to study entry are eligible.
    15. Anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy or tumor embolization) or investigational agent within 28 days prior to study entry
    16. Known or suspected allergy to any component of telatinib, cisplatin or capecitabine
    17. Known dihydropyrimidine dehydrogenase (DPD) deficiency
    18. Unable to take oral medications (because of certain circumstances such as malabsorption, difficulty swallowing, or other conditions) that could affect oral intake of capecitabine and telatinib
    19. Prior or current history of substance abuse, or medical, psychological, or social condition that in the opinion of the investigator may interfere with the subject’s participation in the study or evaluation of the study result
    20. Women who are pregnant or breast-feeding
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is PFS. For the primary analysis of PFS, PFS will be measured from
    the date of first study drug administration to the date of first scan that first documents disease
    progression according to RECIST or the date of symptomatic deterioration if it occurs prior
    to progression according to RECIST, or the date of death due to any cause (if occurring
    before progression). For subjects without documented progression or death at the time of
    analysis, the date of PFS will be censored at the last date of tumor assessment. If a subject
    has no tumor assessments after Screening (Baseline), then the subject will be censored at day
    1.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 35
    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 Decision2009-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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