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    Summary
    EudraCT Number:2010-022155-33
    Sponsor's Protocol Code Number:101-09
    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:2011-02-03
    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 number2010-022155-33
    A.3Full title of the trial
    A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study of Idelalisib in Indolent B-Cell Non-Hodgkin Lymphoma
    A.4.1Sponsor's protocol code number101-09
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01282424
    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 Trial Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityGreat Abington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number441223897284
    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
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    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 codeCAL-101, GS-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.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
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    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 codeCAL-101, GS-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.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
    Indolent B-Cell Non-Hodgkin Lymphoma
    E.1.1.1Medical condition in easily understood language
    Indolent B-Cell Non-Hodgkin Lymphoma is a slow-growing, low-grade cancer of the lymphatic system.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029601
    E.1.2Term Non-Hodgkin's lymphoma refractory
    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
    To evaluate tumor regression as determined by ORR in patients receiving Idelalisib for treatment of iNHL refractory to rituximab and alkylating agents
    E.2.2Secondary objectives of the trial
    - To determine the onset, magnitude, and duration of tumor control and of treatment success in patients receiving Idelalisib
    - To characterize HRQL as reported by patients with iNHL receiving Idelalisib
    - To evaluate the effects of Idelalisib on patient performance status
    - To assess the pharmacodynamic effects of Idelalisib
    - To evaluate Idelalisib treatment administration and compliance with Idelalisib therapy
    - To describe the safety profile of Idelalisib
    - To characterize Idelalisib plasma exposure over time
    - To generate pharmacokinetic data with the final tablet formulation of Idelalisib in patients with iNHL (through conduct of a pharmacokinetic sub-study)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A sub-study in ~10 patients will provide detailed pharmacokinetic information specific to administration of the Idelalisib tablet formulation in patients with iNHL. There is no separate study protocol for the sub-study with all activities managed under the main study protocol. Subjects will have the option of participating in the sub-study, but may also decide to not participate in the sub-study and still take part in the main research study.
    E.3Principal inclusion criteria
    Patients must meet all of the following conditions to be eligible for enrollment into the study:
    1. Age ≥18 years.
    2. Karnofsky performance score of ≥60 (Eastern Cooperative Oncology Group [ECOG] performance score of 0, 1, or 2).
    3. Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following based on criteria established by the World Health Organization (WHO) 2008 classification of tumors of haematopoietic and lymphoid tissues:
    - Follicular lymphoma (FL) Grade 1, 2, or 3a
    - Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5 x 10^9/L at the time of diagnosis and on baseline laboratory assessment performed within 4 weeks prior to the start of study drug administration
    - Lymphoplasmacytoid lymphoma (LPL) with or without associated Waldenstroms Macroglobulinemia (WM)
    - Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)
    4. Histological materials documenting diagnosis of lymphoma available for review.
    5. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥1 lesion that measures >2 cm in the longest dimension [LD] and ≥1.0 cm in the longest perpendicular dimension [LPD] as assessed by CT or MRI)
    6. Prior treatment with ≥2 prior chemotherapy- or immunotherapy-based regimens for iNHL.
    7. Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL.
    8. Lymphoma that is refractory to rituximab and to an alkylating agent. Please refer to Study Protocol section 4.1.1 for the definition of refractoriness.
    9. Discontinuation of all other therapies (including radiotherapy or chemotherapy) for the treatment of iNHL ≥3 weeks before initiation of study treatment (Visit 2).
    10. All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before initiation of study treatment (Visit 2) (with the exception of alopecia [Grade ≤2 permitted], neurotoxicity [Grade ≤2 permitted], or bone marrow parameters noted in Table 1 of protocol section 4.1.1 [Grade ≤2 permitted]).
    11. Required baseline laboratory data (within 4 weeks prior to start of study drug administration) as shown in Table 1 (see Study Protocol section 4.1.1).
    12. For men and women of childbearing potential (ie, patients who are not postmenopausal or surgically sterile), willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods.
    13. Willingness and ability to provide written informed consent and to comply with scheduled visits, drug administration plan, imaging studies and contrast dye administration, laboratory tests, other study procedures, and study restrictions.
    14. Evidence of a personally signed informed consent indicating that the patient is aware of the neoplastic nature of the 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.
    15. In the judgment of the investigator, participation in the protocol offers acceptable benefit:risk when considering current iNHL disease status, medical condition, and the potential benefits and risks of alternative treatments for iNHL.
    E.4Principal exclusion criteria
    The presence of any of the following conditions will exclude a patient from study enrollment:
    1. Central nervous system or leptomeningeal lymphoma.
    2. Known histological transformation from iNHL to diffuse large B-cell lymphoma.
    3. History of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥5 years.
    4. Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment (Visit 2).
    5. Pregnancy or breastfeeding.
    6. Ongoing alcohol or drug addiction.
    7. Known history of drug-induced liver injury, chronic active HCV, chronic active HBV, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension.
    8. History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
    9. Ongoing immunosuppressive therapy, including systemic corticosteroids.
    10. Prior therapy with CAL-101
    11. Exposure to another investigational drug within 3 weeks prior to start of study treatment.
    12. Concurrent participation in another therapeutic treatment trial.
    13. Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or impair the assessment of study results.
    E.5 End points
    E.5.1Primary end point(s)
    ORR – defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR or MR for subjects with WM) during Idelalisib treatment; response definitions will be based on standard criteria [Cheson 2007]
    E.5.1.1Timepoint(s) of evaluation of this end point
    A single formal interim analysis is planned solely to determine if there is a sufficient ORR observed early in the study to warrant continuing the study to completion. At the latest, the interim analysis will be completed once 31 patients have been enrolled and completed the 16-week tumor assessment.
    The final study analysis will be performed when all enrolled patients have completed efficacy, safety, and other assessments through 24 weeks of evaluation.
    E.5.2Secondary end point(s)
    - DOR – defined as the interval from the first documentation of CR or PR (or minor response MR for subjects with WM) to the earlier of the first documentation of disease progression or death from any cause
    -Lymph node response rate (LNR) – defined as the proportion of subjects who achieve a ≥50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes
    - TTR – defined as the interval from the start of Idelalisib treatment to the first documentation of CR or PR (or MR for subjects with WM)
    - PFS – defined as the interval from the start of Idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause
    - Changes in HRQL as reported by patients using the FACT-Lym (Appendix C of protocol)
    - Changes in performance status as documented using the Karnofsky performance criteria (Appendix D of protocol)
    - Changes in the plasma concentrations of disease-associated chemokines and cytokines
    - Overall safety profile of Idelalisib characterized by the type, frequency, severity, timing, and relationship to study therapy of any adverse events or abnormalities of physical findings, laboratory tests, or ECGs; drug discontinuations due to adverse events; or serious adverse events
    - Study drug administration as assessed by prescribing records and compliance as assessed by quantification of used and unused drug
    - Idelalisib trough and peak plasma concentrations assessed pre-dose and 1.5 hours post-dose
    - Pharmacokinetic parameters (eg, Tmax, Cmax, trough concentration [Ctrough], AUC) (for patients in pharmacokinetic sub-study)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final study analysis will be performed when all enrolled patients have completed efficacy, safety, and other assessments through 24 weeks of evaluation.
    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 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    France
    Germany
    Italy
    Poland
    Switzerland
    United Kingdom
    United States
    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
    Provided in protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 80
    F.4.2.2In the whole clinical trial 120
    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)
    Provided in 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 Decision2011-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-16
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