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    Summary
    EudraCT Number:2011-006293-72
    Sponsor's Protocol Code Number:GS-US-312-0117
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-006293-72
    A.3Full title of the trial
    A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent GS-1101 (CAL 101) as Therapy for Patients with Previously Treated Chronic Lymphocytic Leukemia. A Companion Trial to Study GS-US-312-0116: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL 101) in Combination with Rituximab as Therapy for Patients with Previously Treated Chronic Lymphocytic Leukemia.
    Studio di estensione di Fase 3, in doppio cieco, per valutare la sicurezza e l'efficacia di due diversi livelli di dosaggio del singolo agente GS-1101 (CAL-101) come terapia per pazienti con leucemia linfocitica cronica precedentemente trattata. Studio associato allo Studio GS-US-312-0116: Studio randomizzato, di Fase 3, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di GS-1101 (CAL-101) in combinazione con rituximab come terapia per la leucemia linfocitica cronica precedentemente trattata.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Double-Blind Extension Study of GS-1101 at Different Dose Levels for Previously Treated CLL patients (a Companion Trial to GS-US-312-0116).
    Studio di estensione di Fase 3, in doppio cieco con diversi livelli di dosaggio di GS-1101 come terapia per pazienti con leucemia linfocitica cronica precedentemente trattata (Studio associato allo Studio GS-US-312-0116).
    A.4.1Sponsor's protocol code numberGS-US-312-0117
    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 Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address199 East Blaine Street
    B.5.3.2Town/ citySeattle, WA
    B.5.3.3Post code98102
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 206 256 4924
    B.5.5Fax number+1 206 832 2012
    B.5.6E-mailthomas.jahn@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 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 nameNA
    D.3.2Product code GS-1101
    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.3.9.1CAS number 870281-82-6
    D.3.9.2Current sponsor codeGS-1101
    D.3.9.3Other descriptive nameCAL-101
    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 Yes
    D.3.11.13.1Other medicinal product typePiccola molecola inibitrice ad uso orale
    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 nameNA
    D.3.2Product code GS-1101
    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.3.9.1CAS number 870281-82-6
    D.3.9.2Current sponsor codeGS-1101
    D.3.9.3Other descriptive nameCAL-101
    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 Yes
    D.3.11.13.1Other medicinal product typePiccola molecola inibitrice ad uso orale
    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 placeboTablet
    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 placeboTablet
    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
    Chronic lymphocytic leukemia (CLL)
    Leucemia linfocitica cronica
    E.1.1.1Medical condition in easily understood language
    Chronic lymphocytic leukemia (CLL)
    Leucemia linfocitica cronica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10008958
    E.1.2Term Chronic lymphocytic leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 determine the effect of GS-1101 on the onset, magnitude, and duration of tumor control; -To compare tumor control in subjects receiving rituximab alone in Study GS-US-312-0116 to that observed in the same subjects when receiving the standard dose of GS-1101 alone in Study GS-US- 312-0117; -To assess the effect of GS-1101 on measures of subject well-being, including overall survival (OS), health related quality of life (HRQL), and performance status; -To assess the effects of GS-1101 on disease associated biomarkers and to evaluate potential mechanisms of resistance to GS-1101; -To characterize exposure to GS-1101 as determined by treatment administration and evaluation of GS-1101 plasma concentrations over time; - To describe the safety profile observed with GS-1101; - To estimate health resource utilisation.
    •Determinare l’effetto di GS-1101 sull’esordio, l’entita' e la durata del controllo del tumore; •Confrontare il controllo del tumore nei soggetti che hanno ricevuto solo rituximab nello Studio GS-US-312-0116 rispetto a quello osservato negli stessi soggetti quando ricevono la dose standard di solo GS-1101 nello Studio GS-US-312-0117; •Valutare l’effetto di GS-1101 sugli indicatori del benessere del soggetto, compresa la sopravvivenza globale, la qualita' di vita correlata alla salute e il performance status; •Valutare gli effetti di GS-1101 sui biomarcatori associati alla patologia e valutare i potenziali meccanismi di resistenza a GS-1101; •Caratterizzare l’esposizione a GS-1101 determinata dalla somministrazione del trattamento e dalla valutazione delle conc. plasmatiche di GS-1101 nel tempo; • Descrivere il profilo di sicurezza di GS-1101 •Stimare l’impiego di risorse sanitarie.
    E.2.2Secondary objectives of the trial
    Determining the effect of GS-1101 on the onset, magnitude, and duration of tumor control; overall survival (OS); health-related quality of life (HRQL); changes in subject performance status; disease-associated biomarkers and potential mechanisms of resistance; safety; health resource utilization.
    - Determinare l'effetto di GS-1101 sull’esordio,l’entita' e la durata del controllo del tumore; sopravvivenza globale (OS); qualita' della vita correlata alla salute (HRQL); variazioni del performance status nei pazienti; determinare biomarkers associati alla patologia e potenziali meccanismi di resistenza; sicurezza; impegno delle risorse sanitarie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participation in Study GS-US-312-0116; - Occurrence of confirmed, definitive CLL progression while receiving study drug therapy (GS 1101/placebo) in Study GS US 312 0116. Note: Definitive disease progression is CLL progression based on standard criteria and occurring for any reason (ie, increasing lymphadenopathy, organomegaly, or bone marrow involvement; decreasing platelet count, hemoglobin, or neutrophil count; or worsening of disease-related symptoms) other than lymphocytosis. Subjects must have confirmation by the sponsor working in collaboration with an independent review committee (IRC) that the disease has progressed on the clinical trial (Study GS-US-312-0116) before receiving secondary GS 1101 therapy on this extension trial (Study GS-US-312-0117); -Presence of radiographically measurable lymphadenopathy (defined as the presence of ≥1 nodal lesion that measures ≥2.0 cm in the longest dimension [LD] and ≥1.0 cm in the longest perpendicular dimension [LPD] as assessed by CT or MRI); -Permanent cessation of Study GS-US-312-0116 treatment (rituximab and GS-1101/placebo) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, systemic corticosteroids, or investigational therapy) for the treatment of CLL; -The time from permanent cessation of Study GS-US-312-0116 treatment (rituximab and/or GS-1101/placebo) and the initiation of Study GS-US-312-0117 therapy is ≤12 weeks. Note: Study procedures performed as part of Study GS-US-312-0116 need not be repeated and can be used as screening procedures for Study GS-US-312-0117 if performed within 4 weeks prior to initiation of study drug therapy on Study GS-US-312-0117; -Karnofsky performance score of ≥40; -Required baseline laboratory data (within 4 weeks prior to initiation of study treatment).
    -Aver partecipato allo Studio GS-US-312-0116; -Insorgenza di progressione definitiva e confermata della LLC mentre ricevono la terapia con il farmaco dello studio (GS-1101/placebo) nello Studio GS-US-312-0116. Nota: la progressione definitiva della malattia e' la progressione della LLC basata su criteri standard e che insorge per qualsiasi ragione (cioe', linfoadenopatia in aumento, organomegalia o coinvolgimento del midollo osseo; riduzione della conta piastrinica, dell'emoglobina o della conta dei neutrofili; oppure peggioramento dei sintomi correlati alla malattia) diversa dalla linfocitosi. I soggetti devono ricevere la conferma dallo sponsor che opera in collaborazione con un comitato di revisione indipendente (Independent Review Committee, IRC) della progressione della malattia durante la sperimentazione clinica principale (Studio GS-US-312-0116) prima di ricevere la terapia secondaria con GS-1101 in questo studio di estensione (Studio GS-US-312-0117); -La presenza di linfadenopatia misurabile (definita come la presenza di ≥1 lesione nodale della misura di ≥2,0 cm nella dimensione massima [Longest Dimension, LD] e ≥1,0 cm nella massima dimensione perpendicolare [Longest Perpendicular Dimension, LPD] in base a valutazione della tomografia computerizzata [CT ] o della risonanza magnetica [RM]); -Cessazione permanente del trattamento dello Studio GS-US-312-0116 (rituximab e/o GS-1101/placebo) e nessuna terapia intercorrente o proseguita (comprese radioterapia, chemioterapia, immunoterapia, corticosteroidi sistemici o terapia sperimentale) per il trattamento della LLC; -Il periodo di tempo dalla cessazione permanente del trattamento dello Studio GS-US-312-0116 (rituximab e/o GS-1101/placebo) e l’inizio della terapia dello Studio GS-US-312-0117 e' ≤12 settimane. Nota: le procedure di studio eseguite nell’ambito dello Studio GS-US-312-0116 non devono essere ripetute e possono essere utilizzate come procedure di screening per lo Studio GS-US-312-0117 se eseguite entro le 4 settimane precedenti l’inizio della terapia con il farmaco dello Studio GS-US-312-0117; -Punteggio del performance status secondo Karnofsky pari a ≥ 40; -Dati di laboratorio richiesti al basale (entro 4 settimane prima dell’inizio del trattamento dello studio).
    E.4Principal exclusion criteria
    Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation); Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of the start of study treatment (Visit 2). Note: Subjects with localized fungal infections of skin or nails are eligible. Subjects may be receiving prophylactic antiviral or antibacterial therapies at the discretion of the investigator; anti-pneumocystis prophylaxis is encouraged; Pregnancy or breastfeeding; Intentional breaking of the blind in Study GS-US-312-0116 by the investigator or the study subject; Concurrent participation in another therapeutic clinical trial; -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.
    Trasformazione istologica nota da LLC in linfoma aggressivo (ovvero, trasformazione di Richter); Evidenza di infezione sistemica batterica, fungina o virale in atto al momento dell’inizio del trattamento dello studio (Visita 2). Nota: i soggetti con infezioni fungine cutanee o ungueali localizzate sono idonei. I soggetti possono ricevere terapie profilattiche antivirali o antibatteriche, a discrezione dello sperimentatore; e' incoraggiata la profilassi anti-Pneumocystis; Gravidanza o allattamento; Violazione intenzionale del cieco nello Studio GS-US-312-0116 da parte dello sperimentatore o del soggetto dello studio; Contemporanea partecipazione ad un’altra sperimentazione clinica terapeutica; Malattia clinicamente significativa pregressa o in atto, condizioni mediche, storia di interventi chirurgici, reperti obiettivi, reperti elettrocardiografici (ECG) o anomalie di laboratorio che, a giudizio dello sperimentatore, potrebbero compromettere la sicurezza del soggetto o la valutazione dei risultati dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS); Overall response rate (ORR); Time to response (TTR); Duration of response (DOR); Time to treatment failure (TTF).
    Determinate la progressione libera da malattia (PFS); Il tasso di risposta globale (ORR); Tempo alla risposta (TTR); Durata della risposta (DOR); Tempo al fallimento del trattamento (TTF).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8-12 weeks.
    Ogni 8-12 settimane.
    E.5.2Secondary end point(s)
    Percent change in lymph node area; Lymph node response rate; Splenomegaly response rate; Hepatomegaly response rate; Platelet response rate; Hemoglobin response rate; Neutrophil response rate.
    Valutare la percentuale di variazione dell'area linfonodale; Tasso di risposta linfonodale; Tasso di risposta splenomegalica; Tasso di risposta epatomegalica; Tasso di risposta piastrinica; Tasso di risposta emoglobinico; Tasso di risposta dei neutrofili.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 8-12 weeks.
    Ogni 8-12 settimane.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    United States
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months30
    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.1.1Number of subjects for this age range: 0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 73
    F.4.2.2In the whole clinical trial 160
    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 physicians.
    Dopo che il paziente avra' completato/terminato la partecipazione allo studio, il trattamento a lungo termine sara' responsabilita' del medico curante.
    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 Decision2012-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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