Clinical trial • Phase II/III • Oncology|Rare Disease
IMETELSTAT SODIUM for Myelodysplastic syndromes (MDS)
Phase II/III trial of IMETELSTAT SODIUM for Myelodysplastic syndromes (MDS).
Overview
- Trial Therapeutic Area
- Oncology|Rare Disease
- Trial Disease
- Myelodysplastic syndromes (MDS)
- Trial Stage
- Phase II/III
- Drug Modality
- Oligonucleotide
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 16-04-2024
- First CTIS Authorization Date
- 22-05-2024
Trial design
Randomised, placebo to imetelstat (placebo; no active substance). imetelstat (imetelstat sodium) intravenous solution; dose unit mg/kg, maximum daily dose amount 7.5 mg/kg reported in product data; specific dosing schedule not specified in the provided documents.-controlled Phase II/III trial in Spain, Belgium, Germany and others.
- Randomised
- Yes
- Comparator
- Placebo to Imetelstat (Placebo; no active substance). IMETELSTAT (imetelstat sodium) intravenous solution; dose unit mg/kg, maximum daily dose amount 7.5 mg/kg reported in product data; specific dosing schedule not specified in the provided documents.
- Target Sample Size
- 60
Eligibility
Recruits 60 Vulnerable population flagged in the record. Country-specific informed consent documents include separate 'Pregnant Partner' ICFs (e.g., listed country ICFs titled 'Pregnant Partner ICF') and extension-phase ICFs; informed consent is obtained from adult participants (≥18). No further details on assent/consent handling for other vulnerable groups are provided in the available data..
- Vulnerable Population
- Vulnerable population flagged in the record. Country-specific informed consent documents include separate 'Pregnant Partner' ICFs (e.g., listed country ICFs titled 'Pregnant Partner ICF') and extension-phase ICFs; informed consent is obtained from adult participants (≥18). No further details on assent/consent handling for other vulnerable groups are provided in the available data.
Inclusion criteria
- {"criterion_text":"- Man or woman ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)\n- In Part 1, diagnosis of myelodysplastic syndromes (MDS) according to WHO criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to C1D1. A local laboratory report from this diagnostic bone marrow aspirate and biopsy must be reviewed and approved by the sponsor. In Part 2, diagnosis of MDS according to WHO criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to Randomization. A sample of the baseline bone marrow aspirate and biopsy must be submitted to the Independent Central Pathology Reviewer for diagnostic confirmation. Central laboratory review is required to confirm diagnosis prior to Randomization.\n- International Prognostic Scoring System (IPSS) low or intermediate-1 risk MDS.\n- Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units transfused over an 8-week period during the 16 weeks prior to C1D1 (Part 1) or Randomization (Part 2); pre-transfusion Hb should be ≤9.0 g/dL to count towards the 4 units total.\n- Has MDS that is relapsed/refractory to ESA treatment; as defined by meeting any one of the criteria below: - Received at least 8 weeks of treatment with a minimum weekly dose of epoetin alfa 40,000 U, epoetin beta 30,000 U or darbepoetin alfa 150 mcg (or equivalent agent/dose), without having achieved a Hb rise ≥1.5 g/dL or decreased RBC transfusion requirement by at least 4 units over 8 weeks - Transfusion dependence or reduction in Hb by ≥1.5 g/dL after hematologic improvement from at least 8 weeks of treatment with therapies outlined in the above inclusion criteria, in the absence of another explanation. - Endogenous serum EPO level >500 mU/mL\n- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2."}
Exclusion criteria
- {"criterion_text":"- Subject has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients.\n- Subject has received an experimental or investigational drug or used an invasive investigational medical device within 30 days prior to C1D1 (Part 1) or Randomization (Part 2) or is currently enrolled in an investigational study.\n- Prior treatment with imetelstat.\n- Have received corticosteroids >30 mg/day prednisone or equivalent, or growth factor treatment within 4 weeks prior to C1D1 (Part 1) or Randomization (Part 2).\n- a) Prior treatment with a hypomethylating agent (eg, azacitidine, decitabine); b) Prior treatment with lenalidomide, thalidomide, or other thalidomide analogues; c) Has received an ESA or any anti-MDS therapy, chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to C1D1 (Part 1) or Randomization (Part 2) (8 weeks for long-acting ESAs)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary efficacy endpoint of this study is the rate of RBC TI lasting at least 8 weeks. The 8-week RBC TI rate is defined as the proportion of subjects without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1. Study Day 1 is defined as the day of the first dose for subjects enrolled in Part 1 and the day of randomization for subjects enrolled in Part 2.","definition_or_measurement_approach":"The 8-week RBC TI rate is defined as the proportion of subjects without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1. Study Day 1 is defined as the day of the first dose for subjects enrolled in Part 1 and the day of randomization for subjects enrolled in Part 2."}
Secondary endpoints
- {"endpoint_text":"- Safety of imetelstat in subjects with MDS (eg, incidence, intensity, and type of adverse events, vital signs measurements, clinical laboratory values, ECGs changes, and deaths)","definition_or_measurement_approach":"Safety assessed by incidence, intensity, and type of adverse events, vital signs, clinical lab values, ECG changes, and deaths."}
- {"endpoint_text":"- 24-week RBC TI rate, defined as the proportion of subjects without any RBC transfusion during any consecutive 24 weeks (168 days) starting from Study Day 1","definition_or_measurement_approach":"Defined as the proportion of subjects without any RBC transfusion during any consecutive 24 weeks (168 days) starting from Study Day 1."}
- {"endpoint_text":"- Time to the 8-week (24 week) RBC TI, defined as the interval from Study Day 1 to the first day of the first 8-week (24 week) RBC TI period","definition_or_measurement_approach":"Interval from Study Day 1 to the first day of the first 8-week (24-week) RBC TI period."}
- {"endpoint_text":"- Duration of RBC TI, defined as the first day of the longest RBC TI period to the date of the first RBC transfusion after the TI period starts","definition_or_measurement_approach":"Duration measured from the first day of the longest RBC TI period to the date of the first RBC transfusion after the TI period starts."}
- {"endpoint_text":"- Rate of hematologic improvement, including HI-E, per modified IWG 2006","definition_or_measurement_approach":"Rate assessed per modified IWG 2006 criteria (including HI-E)."}
- {"endpoint_text":"- Rates of CR, PR, or mCR per modified IWG 2006","definition_or_measurement_approach":"Rates assessed per modified IWG 2006 criteria."}
- {"endpoint_text":"- OS, defined as the interval from Study Day 1 to death from any cause. Survival time of living subjects will be censored on the last date a subject is known to be alive or lost to follow-up","definition_or_measurement_approach":"OS defined as interval from Study Day 1 to death from any cause; living subjects censored at last known alive date or lost to follow-up."}
- {"endpoint_text":"- Progression free survival, defined as the time interval from Study Day 1 to the first date of disease progression or death from any cause, whichever occurs first. For subjects who do not have documented disease progression and who are still alive at the end of the study or clinical cutoff will be censored at the last disease evaluation date.","definition_or_measurement_approach":"PFS defined as time from Study Day 1 to first date of disease progression or death; subjects without documented progression censored at last disease evaluation date."}
- {"endpoint_text":"- Time to progression to AML, defined as the interval from Study Day 1 to the date of AML diagnosis. For subjects who have not progressed to AML and are still alive at the cutoff date for the analysis or who withdraw from the study (withdrawal of consent or lost to follow-up), data will be censored at the date of the last disease evaluation","definition_or_measurement_approach":"Interval from Study Day 1 to date of AML diagnosis; subjects not progressed censored at date of last disease evaluation."}
- {"endpoint_text":"- Amount and relative change in RBC transfusions","definition_or_measurement_approach":"Amount and relative change in RBC transfusions measured over study period."}
- {"endpoint_text":"- Rate of myeloid growth factors usage, defined as the proportion of subjects receive any myeloid growth factors starting from Study Day 1; duration of myeloid growth factor administered starting from Study Day 1","definition_or_measurement_approach":"Proportion of subjects receiving any myeloid growth factors from Study Day 1 and duration of administration starting from Study Day 1."}
- {"endpoint_text":"- Assessment of QUALMS, FACT-An, and EQ-5D-5L","definition_or_measurement_approach":"Assessment using patient-reported outcome instruments QUALMS, FACT-An, and EQ-5D-5L."}
- {"endpoint_text":"- Pharmacokinetic parameters (eg, Cmax, AUC0-t), and immunogenicity of imetelstat (eg, antibodies to imetelstat)","definition_or_measurement_approach":"Pharmacokinetic parameters (Cmax, AUC0-t etc.) and immunogenicity assessment (antibodies to imetelstat)."}
- {"endpoint_text":"- Medical resource utilization data including hospitalization, emergency room visits, and hematology specialist visits","definition_or_measurement_approach":"Medical resource utilization captured including hospitalizations, ER visits, and hematology specialist visits."}
- {"endpoint_text":"- ECG parameters including change in QT interval by Fridericia's correction method (ΔQTcF) in the Ventricular Repolarization substudy (Part 2 only)","definition_or_measurement_approach":"ECG parameters measured; ΔQTcF by Fridericia correction in Ventricular Repolarization substudy (Part 2 only)."}
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 131
- Consent Approach
- Informed consent is obtained from adult participants (≥18 years). Country-specific subject information and informed consent forms are provided (documents list includes English, Spanish, French, Dutch, Czech, German, Italian, Polish versions and country-specific ICFs). Separate 'Pregnant Partner' ICFs and extension-phase ICFs are listed for some countries. No further details on assent or consent for other vulnerable groups are provided in the available data.
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 164
Spain
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 03-12-2025
- Processing Time Days
- 579
- Number Of Sites
- 9
- Number Of Participants
- 18
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- ES10004: Hematología
- Principal Investigator Name
- Blanca Xicoy Cirici
- Principal Investigator Email
- bxicoy@iconcologia.net
- Contact Person Name
- Blanca Xicoy Cirici
- Contact Person Email
- bxicoy@iconcologia.net
- Site Name
- Hospital Universitario Virgen De Valme
- Department Name
- ES10053: Oncologia Médica
- Principal Investigator Name
- Maria Vahi Sanchez de Medina
- Principal Investigator Email
- mariavahi@gmail.com
- Contact Person Name
- Maria Vahi Sanchez de Medina
- Contact Person Email
- mariavahi@gmail.com
- Site Name
- Hospital Universitario De Cruces
- Department Name
- ES10054: Hematologia
- Principal Investigator Name
- Miriam Vara Pampliega
- Principal Investigator Email
- miriam.varapampliega@osakidetza.eus
- Contact Person Name
- Miriam Vara Pampliega
- Contact Person Email
- miriam.varapampliega@osakidetza.eus
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- ES10002: Hematología
- Principal Investigator Name
- Maria Diez Campelo
- Principal Investigator Email
- mdiezcampelo@usal.es
- Contact Person Name
- Maria Diez Campelo
- Contact Person Email
- mdiezcampelo@usal.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- ES10006: Hematologia
- Principal Investigator Name
- Patricia Font Lopez
- Principal Investigator Email
- patricia.font@salud.madrid.org
- Contact Person Name
- Patricia Font Lopez
- Contact Person Email
- patricia.font@salud.madrid.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- ES10003: Hematología y Transfusión
- Principal Investigator Name
- David Valcarcel Ferreiras
- Principal Investigator Email
- dvalcarcelct@vhio.net
- Contact Person Name
- David Valcarcel Ferreiras
- Contact Person Email
- dvalcarcelct@vhio.net
- Site Name
- Hospital Universitario La Paz
- Department Name
- ES10005: Hematología
- Principal Investigator Name
- Maria Raquel De Paz Arias
- Principal Investigator Email
- depazraquel@gmail.com
- Contact Person Name
- Maria Raquel De Paz Arias
- Contact Person Email
- depazraquel@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- ES10055: Hematología y Hemoterapia
- Principal Investigator Name
- Emilio Ojeda Gutierrez
- Principal Investigator Email
- emilio.ojeda@salud.madrid.org
- Contact Person Name
- Emilio Ojeda Gutierrez
- Contact Person Email
- emilio.ojeda@salud.madrid.org
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- ES10050: Hematologia
- Principal Investigator Name
- Elvira Mora Castera
- Principal Investigator Email
- mora_elv@gva.es
- Contact Person Name
- Elvira Mora Castera
- Contact Person Email
- mora_elv@gva.es
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 13-11-2025
- Processing Time Days
- 559
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- BE10008: Haematology
- Principal Investigator Name
- Bert Heyrman
- Principal Investigator Email
- Bert.Heyrman@zas.be
- Contact Person Name
- Bert Heyrman
- Contact Person Email
- Bert.Heyrman@zas.be
- Site Name
- Algemeen Ziekenhuis Klina
- Department Name
- BE10004: Oncology
- Principal Investigator Name
- Stef Meers
- Principal Investigator Email
- stef.meers@klina.be
- Contact Person Name
- Stef Meers
- Contact Person Email
- stef.meers@klina.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- BE10002: Oncology
- Principal Investigator Name
- Koen Van Eygen
- Principal Investigator Email
- koen.vaneygen@azgroeninge.be
- Contact Person Name
- Koen Van Eygen
- Contact Person Email
- koen.vaneygen@azgroeninge.be
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- BE10007: Hematology
- Principal Investigator Name
- Tom Lodewyck
- Principal Investigator Email
- tom.lodewyck@azsintjan.be
- Contact Person Name
- Tom Lodewyck
- Contact Person Email
- tom.lodewyck@azsintjan.be
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- BE10052: Hematologie
- Principal Investigator Name
- Bert Heyrman
- Principal Investigator Email
- Bert.Heyrman@zas.be
- Contact Person Name
- Bert Heyrman
- Contact Person Email
- Bert.Heyrman@zas.be
Germany
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 570
- Number Of Sites
- 5
- Number Of Participants
- 21
Sites
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- DE10005:Thoracic Surgery
- Principal Investigator Name
- Michael Lubbert
- Principal Investigator Email
- michael.luebbert@uniklinik-freiburg.de
- Contact Person Name
- Michael Lubbert
- Contact Person Email
- michael.luebbert@uniklinik-freiburg.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- DE10001:Klinik für Hämatologie,Onkologie und Klinische Immunologie
- Principal Investigator Name
- Ulrich Germing
- Principal Investigator Email
- germing@med.uni-duesseldorf.de
- Contact Person Name
- Ulrich Germing
- Contact Person Email
- germing@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- DE10050:Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
- Principal Investigator Name
- Dominic Brauer
- Principal Investigator Email
- dominic.brauer@medizin.uni-leipzig.de
- Contact Person Name
- Dominic Brauer
- Contact Person Email
- dominic.brauer@medizin.uni-leipzig.de
- Site Name
- Gemeinschaftspraxis Haematologie Onkologie
- Department Name
- DE10053:Jacobasch, Illmer, Wolf
- Principal Investigator Name
- Thomas Illmer
- Principal Investigator Email
- illmer@onkologie-dresden.net
- Contact Person Name
- Thomas Illmer
- Contact Person Email
- illmer@onkologie-dresden.net
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- DE10003:Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Katja Sockel
- Principal Investigator Email
- katja.sockel@uniklinikum-dresden.de
- Contact Person Name
- Katja Sockel
- Contact Person Email
- katja.sockel@uniklinikum-dresden.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 19-12-2025
- Processing Time Days
- 595
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Meander Medisch Centrum
- Department Name
- NL10005; Nephrology
- Principal Investigator Name
- Rob Fijnheer
- Principal Investigator Email
- r.fijnheer@meandermc.nl
- Contact Person Name
- Rob Fijnheer
- Contact Person Email
- r.fijnheer@meandermc.nl
Czechia
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 18-11-2025
- Processing Time Days
- 564
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- CZ10052 : Interni hematologicka klinika
- Principal Investigator Name
- Olga Cerna
- Principal Investigator Email
- malu@email.cz
- Contact Person Name
- Olga Cerna
- Contact Person Email
- malu@email.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- CZ10050 : Int. hemat. a onkol. klinika
- Principal Investigator Name
- Jiri Mayer
- Principal Investigator Email
- mayer.jiri@fnbrno.cz
- Contact Person Name
- Jiri Mayer
- Contact Person Email
- mayer.jiri@fnbrno.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- CZ10051 : IV. interni hematologicka klinika
- Principal Investigator Name
- Petra Belohlavkova
- Principal Investigator Email
- petra.belohlavkova@fnhk.cz
- Contact Person Name
- Petra Belohlavkova
- Contact Person Email
- petra.belohlavkova@fnhk.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- CZ10053 : I. Interni klinika - klinika hematologie VFN a 1. LF UK v Praze
- Principal Investigator Name
- Anna Jonasova
- Principal Investigator Email
- anna.jonasova@vfn.cz
- Contact Person Name
- Anna Jonasova
- Contact Person Email
- anna.jonasova@vfn.cz
France
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 17-11-2025
- Processing Time Days
- 563
- Number Of Sites
- 5
- Number Of Participants
- 60
Sites
- Site Name
- Hopital Saint Louis
- Department Name
- FR10001: Hematologie - Cancerologie
- Principal Investigator Name
- Pierre Fenaux
- Principal Investigator Email
- pierre.fenaux@aphp.fr
- Contact Person Name
- Pierre Fenaux
- Contact Person Email
- pierre.fenaux@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- FR10052: Pole Regional de Cancerologie
- Principal Investigator Name
- Jose Miguel TORREGROSA-DIAZ
- Principal Investigator Email
- jose-miguel.torregrosa-diaz@chu-poitiers.fr
- Contact Person Name
- Jose Miguel TORREGROSA-DIAZ
- Contact Person Email
- jose-miguel.torregrosa-diaz@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- FR10051: Service des Maladies du Sang
- Principal Investigator Name
- Laure Goursaud
- Principal Investigator Email
- laure.goursaud@chu-lille.fr
- Contact Person Name
- Laure Goursaud
- Contact Person Email
- laure.goursaud@chu-lille.fr
- Site Name
- Centre Hospitalier Regional D'Angers
- Department Name
- FR10006: Cancero Solide UTTIOM
- Principal Investigator Name
- Sylvain Thepot
- Principal Investigator Email
- sylvain.thepot@chu-angers.fr
- Contact Person Name
- Sylvain Thepot
- Contact Person Email
- sylvain.thepot@chu-angers.fr
- Site Name
- Centre Hospitalier Le Mans
- Department Name
- FR10054: HEMATOLOGIE
- Principal Investigator Name
- Kamel Laribi
- Principal Investigator Email
- klaribi@ch-lemans.fr
- Contact Person Name
- Kamel Laribi
- Contact Person Email
- klaribi@ch-lemans.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 15-11-2025
- Processing Time Days
- 561
- Number Of Sites
- 2
- Number Of Participants
- 18
Sites
- Site Name
- Pratia S.A.
- Department Name
- PL10052: PRATIA Poznan
- Principal Investigator Name
- Maciej Kazmierczak
- Principal Investigator Email
- maciej.kazmierczak@onet.eu
- Contact Person Name
- Maciej Kazmierczak
- Contact Person Email
- maciej.kazmierczak@onet.eu
- Site Name
- Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Department Name
- PL10051:Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku
- Principal Investigator Name
- Janusz Halka
- Principal Investigator Email
- janusz.halka@poliklinika.net
- Contact Person Name
- Janusz Halka
- Contact Person Email
- janusz.halka@poliklinika.net
Italy
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 17-11-2025
- Processing Time Days
- 563
- Number Of Sites
- 5
- Number Of Participants
- 22
Sites
- Site Name
- Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
- Department Name
- IT10052: Ematologia
- Principal Investigator Name
- Daniela Barraco
- Principal Investigator Email
- daniela.barraco@asst-settelaghi.it
- Contact Person Name
- Daniela Barraco
- Contact Person Email
- daniela.barraco@asst-settelaghi.it
- Site Name
- Grande Ospedale Metropolitano Bianchi Melacrino Morelli
- Department Name
- IT10004: U.O Ematologia
- Principal Investigator Name
- Caterina Alati
- Principal Investigator Email
- caterina.alati@gmail.com
- Contact Person Name
- Caterina Alati
- Contact Person Email
- caterina.alati@gmail.com
- Site Name
- IRCCS Centro Di Riferimento Oncologico Della Basilicata
- Department Name
- IT10050: Ematologia
- Principal Investigator Name
- Giuseppe Pietrantuono
- Principal Investigator Email
- giuseppe.pietrantuono@crob.it
- Contact Person Name
- Giuseppe Pietrantuono
- Contact Person Email
- giuseppe.pietrantuono@crob.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- IT10053: Oncologia Medica ed Ematologia
- Principal Investigator Name
- Matteo Giovanni Della Porta
- Principal Investigator Email
- matteo.della_porta@hunimed.eu
- Contact Person Name
- Matteo Giovanni Della Porta
- Contact Person Email
- matteo.della_porta@hunimed.eu
- Site Name
- Careggi University Hospital
- Department Name
- IT10002: Ophtalmology
- Principal Investigator Name
- Valeria Santini
- Principal Investigator Email
- valeria.santini@unifi.it
- Contact Person Name
- Valeria Santini
- Contact Person Email
- valeria.santini@unifi.it
Sponsor
Primary sponsor
- Full Name
- Geron Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- Regulatory and clinical operations (codes include regulatory submissions, clinical operations and trial management as listed)
- Name
- Medidata Solutions Inc.
- Responsibilities
- Clinical data systems and related services (codes 6 and 7)
Third parties
- {"country":"United States","full_name":"CRF Bracket","duties_or_roles":"IVRS - treatment randomisation","organisation_type":"Industry"}
- {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"Regulatory safety information","organisation_type":"Pharmaceutical company"}
- {"country":"Croatia","full_name":"Primevigilance Zagreb d.o.o.","duties_or_roles":"(role code 8) [specific duty not detailed in record]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic data capture and related clinical trial systems (codes 6 and 7)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac sub-study","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Multiple sponsor functions including regulatory, clinical trial management and other operational duties (codes 1,10,11,12,2,8,9)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Biomarkers, PK and immunogenicity (blood samples) and related laboratory sub-contracting duties","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- IMETELSTAT
- Active Substance
- IMETELSTAT SODIUM
- Modality
- Oligonucleotide
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Orphan Designation
- Yes
- Maximum Dose
- 7.5 mg/kg
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- LISOCABTAGENE MARALEUCEL for Follicular lymphoma | Marginal zone lymphoma | Relapsed or refractory indolent B-cell non-Hodgkin lymphoma
- MIRDAMETINIB for Neurofibromatosis type 1 associated plexiform neurofibroma
- (12M)-(1S,2S)-N-((63S,4S,Z)-11-ETHYL-12-(2-((S)-1-METHOXYETHYL)-5-(4-METHYLPIPERAZIN-1-YL)PYRIDIN-3-YL)-10,10-DIMETHYL-5,7-DIOXO-61,62,63,64,65,66-HEXAHYDRO-11H-8-OXA-2(4,2)-THIAZOLA-1(5,3)-INDOLA-6(1,3)-PYRIDAZINACYCLOUNDECAPHANE-4-YL)-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE for Resected pancreatic ductal adenocarcinoma (PDAC)
- REVUMENIB for Acute Myeloid Leukemia
- N-[[(2S)-4-[(4-METHYL-1H-IMIDAZOL-5-YL)METHYL]-3-OXO-2-(PHENYLMETHYL)-1-PIPERAZINYL]CARBONYL]-L-LEUCINE TRIHYDRATE for Cutaneous T-cell lymphoma