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    Summary
    EudraCT Number:2015-000366-66
    Sponsor's Protocol Code Number:GS-US-313-1580
    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:2015-09-28
    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 number2015-000366-66
    A.3Full title of the trial
    Dose Optimization Study of Idelalisib in Follicular Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to optimize the dose of Idelalisib in Follicular Lymphoma
    A.4.1Sponsor's protocol code numberGS-US-313-1580
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223897284
    B.5.6E-mailclinical.trials@gilead.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 Yes
    D.2.1.1.1Trade name Zydelig 100 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIdelalisib
    D.3.2Product code IDELA, GS-1101
    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 INNIDELALISIB
    D.3.9.1CAS number 870281-82-6
    D.3.9.2Current sponsor codeGS-1101
    D.3.9.3Other descriptive nameIDELA
    D.3.9.4EV Substance CodeSUB126168
    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 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 Yes
    D.2.1.1.1Trade name Zydelig 150 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIdelalisib
    D.3.2Product code IDELA, GS-1101
    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 INNIDELALISIB
    D.3.9.1CAS number 870281-82-6
    D.3.9.2Current sponsor codeGS-1101
    D.3.9.3Other descriptive nameIDELA
    D.3.9.4EV Substance CodeSUB126168
    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
    D.8 Placebo: 2
    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
    Follicular Lymphoma
    E.1.1.1Medical condition in easily understood language
    Follicular Lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10065856
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology indolent
    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
    Establish a safe and effective dosing regimen of idelalisib in subjects with relapsed or refractory FL who have no other therapeutic options
    E.2.2Secondary objectives of the trial
    - Evaluate the overall response rate (ORR)
    - Evaluate the progression-free survival (PFS), duration of response (DOR), and overall survival (OS)
    - Evaluate the overall safety profile of idelalisib
    - Determine the PK of idelalisib and its major metabolite (GS-563117)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥ 18 years of age
    2. Histologically confirmed diagnosis of B-cell FL, and grade limited to 1, 2 or 3a based on criteria established by the WHO 2008 classification of tumors of hematopoietic and lymphoid tissues
    3. Relapsed or refractory FL and have received at least 2 lines of prior therapy for FL and have no other therapeutic options
    4. Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease per Lugano Classification
    5. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures ≥ 1.5 cm in the LD and ≥ 1.0 cm in the LPD as assessed by PET CT, CT or MRI)
    6. Has adequate performance status (such as ECOG Performance Status of ≤ 2 or Karnofsky Performance Status of ≥ 60)
    7. Required baseline central laboratory data (within 4 weeks prior to start of study therapy) as shown in the table in the protocol.
    8. For female subjects of childbearing potential, willingness to use a protocol recommended method of contraception during heterosexual intercourse from the signing of informed consent throughout the study treatment period and up to 30 days from the last dose of idelalisib (see Protocol)
    9. For male subjects of reproductive potential having intercourse with females of childbearing potential, willing to use a protocol recommended method of contraception during heterosexual intercourse and to refrain from sperm donation throughout the study treatment period and for 90 days following discontinuation of idelalisib (see Protocol)
    10. Lactating females must agree to discontinue nursing before study drug administration and at least 30 days following exposure
    11. Indicate willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions
    12. Evidence of a signed informed consent indicating that the subject is aware of the neoplastic nature of their disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, possible side effects, potential risks and discomforts, and other pertinent aspects of study participation
    E.4Principal exclusion criteria
    1. History of lymphoid malignancy other than FL (eg, DLBCL)
    2. Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
    3. Known presence of intermediate- or high-grade myelodysplastic syndrome
    4. Known history of serious allergic reaction including anaphylaxis or Stevens-Johnson syndrome/toxic epidermal necrolysis
    5. History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or any other cancer or malignancy that has been in complete remission for ≥ 5 years
    6. Evidence of ongoing systemic infection (eg, bacterial, fungal, viral) at the time of enrollment
    7. Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
    8. History of or on-going drug-induced pneumonitis
    9. History of or on-going inflammatory bowel disease
    10. Known human immunodeficiency virus (HIV) infection
    11. CMV: On-going infection, treatment, or prophylaxis within 28 days prior to the Screening Visit CMV test
    12. Presence of any condition that could, in the opinion of the investigator, compromise the subject’s ability to participate in the study, such as history of substance abuse, alcoholism, or a psychiatric condition
    13. History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
    14. Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions or systemic corticosteroids for autoimmune anemia and/or thrombocytopenia
    15. Concurrent participation in another therapeutic clinical trial
    16. Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results
    17. Prior treatment with PI3K inhibitors
    E.5 End points
    E.5.1Primary end point(s)
    - Overall response rate (ORR) defined as the proportion of subjects who achieve a partial response (PR) or complete response (CR)
    - Incidence of Grade ≥ 4 treatment-emergent adverse events (TEAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinic visits will occur at Screening, Day 1, every 2 weeks through Week 12, every 4 weeks through Week 24, at Week 32, 36, 40, 48, and every 12 weeks thereafter through end of study (EOS). Subjects will be assessed for safety at each visit. Additional visits will be required
    between clinic visits for laboratory testing only.

    Subjects will be assessed for FL disease status by continuous utilization of a single modality including positron emission tomography–computed
    tomography (PET-CT), computed tomography (CT), or magnetic resonance imaging (MRI). Exact timing for radiographic assessments is described in section 6.1.7 of protocol including scenarios for subjects recruited before and after Protocol amendment 5.
    E.5.2Secondary end point(s)
    - DOR, defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression by IRC or
    death from any cause
    - ORR by Week 24, defined as the proportion of subjects who achieve a PR or CR by Week 24
    - Overall safety profile of idelalisib, including the incidence of adverse events (AEs) and clinically significant laboratory abnormalities, severity, timing, and relationship to idelalisib of any AEs; SAEs; or AEs leading to interruption, reduction, or discontinuation of idelalisib
    - Time to onset of AEs of interest (AEIs) defined as the interval from the start of idelalisib treatment to the first documentation of start of AEI
    - PFS, defined as the interval from randomization to the earlier of the first documentation of disease progression by IRC or death from any
    cause
    - OS, defined as the interval from randomization to death from any cause
    - Idelalisib trough (pre-dose) and peak (1.5-hour samples) plasma concentrations assessed by validated bioanalytical method
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinic visits will occur at Screening, Day 1, every 2 weeks through Week 12, every 4 weeks through Week 24, at Weeks 32, 36, 40, 48, and every
    12 weeks thereafter through end of study (EOS). Subjects will be assessed for safety at each visit. Additional visits will be required
    between clinic visits for laboratory testing only.

    Subjects will be assessed for FL disease status by continuous utilization of a single modality including positron emission tomography–computed
    tomography (PET-CT), computed tomography (CT), or magnetic resonance imaging (MRI). Exact timing for radiographic assessments is
    described in section 6.1.7 of protocol including scenarios for subjects recruited before and after Protocol amendment 5.
    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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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
    Australia
    Canada
    Israel
    United States
    Czechia
    France
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    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
    End of trial is considered end of long term follow up (LTFU), which is 5 years after LVLS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    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 years15
    E.8.9.2In all countries concerned by the trial months0
    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: 123
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 123
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 266
    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 patient has completed / terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physician
    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 Decision2015-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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