Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
50
Countries
6
Sites
13
IDH1-mutant Glioma
1. To evaluate the safety and tolerability of vorasidenib when administered in combination with TMZ and determine (for Phase 1b) the RCD. 2. To assess preliminary clinical efficacy of vorasidenib in combination with TMZ based on the PFS rate at 12 months (per RANO 2.0) for participants with IDHm Grade 4 astrocytoma enr…
Key facts
- Sponsor
- Institut De Recherches Internationales Servier IRIS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Mar 2025 → ongoing
- Decision date (initial)
- 2025-02-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ADIR France · Laboratorios Servier, S. L
External identifiers
- EU CT number
- 2024-513738-39-00
- ClinicalTrials.gov
- NCT06478212
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Safety, Efficacy, Therapy, Pharmacodynamic, Pharmacokinetic
1. To evaluate the safety and tolerability of vorasidenib when administered in combination with TMZ and determine (for Phase 1b) the RCD.
2. To assess preliminary clinical efficacy of vorasidenib in combination with TMZ based on the PFS rate at 12 months (per RANO 2.0) for participants with IDHm Grade 4 astrocytoma enrolled in Phase 2 and Phase 1b and treated at the RCD.
Secondary objectives 3
- To assess other parameters of clinical efficacy of vorasidenib in combination with TMZ based on PFS, OS, ORR, and CBR for participants with IDHm Grade 4 astrocytoma enrolled in Phase 2 and Phase 1b and treated at the RCD
- To characterize the PK of vorasidenib and its metabolite AGI-69460 in plasma when vorasidenib is given in combination with TMZ and when given alone
- To characterize the PK of TMZ in plasma when TMZ is given in combination with vorasidenib (Phase 1b only)
Conditions and MedDRA coding
IDH1-mutant Glioma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018338 | Glioma | 100000004864 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 1b: Vorasidenib and Temozolomide (TMZ) It is on open-label study
|
Not Applicable | None | Phase 1b: Vorasidenib and Temozolomide (TMZ): Vorasidenib: To be taken by mouth once daily in 28-day cycles with no break between cycles Temozolomide (TMZ): To be taken by mouth once daily for the first 5 days of each 28-day cycle, for a maximum of 12 cycles |
|
| 2 | Phase 2: Vorasidenib recommended combination dose (RCD) and Temozolomide (TMZ) It is on open-label study
|
Not Applicable | None | Phase 2: Vorasidenib recommended combination dose (RCD) and Temozolomide (TMZ): Vorasidenib: To be taken by mouth once daily in 28-day cycles with no break between cycles Temozolomide (TMZ): To be taken by mouth once daily for the first 5 days of each 28-day cycle, for a maximum of 12 cycles |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 15
- Be ≥18 years of age with a weight at screening ≥40 kg.
- Have documented IDH1 or IDH2 mutation based on local testing of tumor tissue by an accredited laboratory.
- Have adequate renal function, defined as a creatinine clearance ≥40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation
- Have adequate bone marrow function as evidenced by: - Absolute neutrophil count ≥1,500/mm3 or 1.5×109/L - Hemoglobin ≥9 g/dL or 90 g/L - Platelets ≥100,000/mm3 or 100×109/L
- Have recovered from any clinically relevant toxicities associated with previous anticancer therapy unless they are stable and manageable per Investigator’s judgment.
- Have expected survival of ≥3 months.
- KPS ≥70 at the start of study treatment.
- Participants on corticosteroids for reasons related to glioma must be on a stable or decreasing dose (≤4mg/day dexamethasone or equivalent) for ≥5 days before the start of study treatment.
- Female participants of reproductive potential must have a negative serum pregnancy test before starting study treatment. Female participants of reproductive potential are defined as having had onset of their first menstrual period and have not undergone a hysterectomy or bilateral oophorectomy or are not naturally postmenopausal (i.e., have not menstruated in the preceding 24 consecutive months).
- "Phase 1b ONLY: Have histologically confirmed Grade 2, 3 or 4 IDHm (as per WHO 2021) glioma (astrocytoma or oligodendroglioma). 1. For oligodendroglioma: Have local testing at an accredited laboratory demonstrating presence of 1p19q co deletion 2. For astrocytoma: Have local testing by an accredited laboratory demonstrating lack of 1p19q co-deletion and/or documented loss of nuclear ATRX expression or ATRX mutation"
- Phase 1b ONLY: Are appropriate to receive TMZ as post-radiotherapy (RT) adjuvant therapy or as treatment for first disease recurrence after prior RT and/or chemotherapy, per Investigator judgement. For those receiving TMZ in the post-RT adjuvant setting, study treatment must begin no more than 6 weeks after completion of RT.
- Have adequate hepatic function as evidenced by: 1. Serum total bilirubin ≤1.5×upper limit of normal (ULN); if ≥1.5×ULN and due to Gilbert syndrome, total bilirubin ≤3×ULN with direct bilirubin ≤ULN, 2. AST and ALT ≤ULN, An elevation ≤1.5×ULN. For phase 2, an elevation ≤1.5×UL considered not clinically significant by the Investigator may be allowed after Sponso) approval, and 3. Alkaline phosphatase ≤2.5×ULN.
- Phase 2 ONLY: Have histologically confirmed Grade 4 astrocytoma, IDHm (per 2021 WHO criteria). Those who meet the Grade 4 designation via homozygous deletion of CDKN2A/B are eligible.
- Phase 2 ONLY: Have absence of 1p19q co-deletion (i.e., non-co-deleted, or intact) and/or documented loss of nuclear ATRX expression or ATRX mutation by local testing.
- Phase 2 ONLY: Have received SOC RT with concurrent TMZ (RT-TMZ) before enrollment. Study treatment must begin no more than 6 weeks after completion of RT-TMZ.
Exclusion criteria 19
- Unable to swallow oral medication.
- Are pregnant or breastfeeding.
- "Are participating in another interventional study at the same time; participation in non-interventional registries or epidemiological studies is allowed."
- Have leptomeningeal disease.
- Have a known coagulopathy.
- Received prior therapy with an IDH inhibitor, IDH-directed vaccine, or bevacizumab.
- Have a history of another concurrent primary cancer, with the exception of: 1. curatively resected non-melanoma skin cancer, or 2. curatively treated carcinoma in situ. Participants with other previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.
- Have a known diagnosis of replication repair-deficient glioma (e.g., a known diagnosis of constitutional mismatch repair deficiency or Lynch syndrome).
- Have a known hypersensitivity to any of the components or metabolites of vorasidenib or TMZ.
- Have significant active cardiac disease within 6 months before Screening, including New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke.
- Have heart rate corrected QT interval (using Fridericia's formula) (QTcF) ≥450 msec or have other factors that increase risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome). Right bundle branch block and prolonged QTcF interval may be permitted based on local cardiology assessment.
- Are taking medications that are substrates of CYP2C19 or CYP3A with a narrow therapeutic index or taking medications that are strong CYP1A2 inhibitors. Participants should be transferred to other medications before receiving the first dose of study treatment"
- Have known active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness. Participants with a sustained viral response to HCV treatment will be permitted. Participants with chronic HIV that is adequately suppressed per institutional practice will be permitted. Participants with evidence of prior HBV infection will be excluded.
- Phase 1b ONLY: For participants receiving TMZ in the frontline post-RT adjuvant setting: Have progressive disease during RT or after completion of SOC RT and before the start of study treatment.
- Phase 1b ONLY: For participants receiving TMZ in the recurrent disease setting: Have received prior systemic anti-cancer therapy (other than surgery) within 1 month (or 6 weeks for nitrosoureas and 6 months for TMZ) of the start of study treatment. In addition, the first dose of study treatment should not occur before a period of 28 days or ≥5 half-lives of any prior investigational agent have elapsed, whichever is longer. Have received more than one prior line of therapy for glioma (Note: prior RT + chemotherapy is considered one line of therapy)."
- Had Grade ≥2 hepatic-related toxicity (AST, ALT, and/or bilirubin elevations) during prior systemic chemotherapy (for phase 1b) or during concurrent RT-TMZ (phase 2)
- Had Grade 4 hematologic toxicity (excluding lymphopenia) that did not recover within 7 days during a prior course of TMZ
- Phase 2 ONLY: Have received any other glioma-directed therapy other than surgery and SOC RT-TMZ
- Phase 2 ONLY: Have progressive disease during RT-TMZ or after completion of SOC RT-TMZ
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- DLTs (for Phase 1b only), incidence and severity of AEs, SAEs, and AESIs
- Progression-free Survival (PFS) status at 12 months
Secondary endpoints 2
- PFS, OS, OR, and clinical benefit (CR+ PR+SD)
- Plasma concentrations and PK parameters of vorasidenib and its metabolite AGI-69460 and TMZ
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 25
Temozolomide ratiopharm 180 mg, capsules, hard
PRD1735687 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- RVG 104513
- MA holder
- RATIOPHARM GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide ratiopharm 5 mg, capsules, hard
PRD604782 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- RVG 104502
- MA holder
- RATIOPHARM GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide ratiopharm 100 mg, capsules, hard
PRD604439 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- RVG 104511
- MA holder
- RATIOPHARM GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide ratiopharm 140 mg, capsules, hard
PRD605212 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- RVG 104512
- MA holder
- RATIOPHARM GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide ratiopharm 250 mg, capsules, hard
PRD604436 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- RVG 104514
- MA holder
- RATIOPHARM GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide ratiopharm 20 mg, capsules, hard
PRD604127 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- RVG 104510
- MA holder
- RATIOPHARM GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
PRD11331943 · Product
- Active substance
- Vorasidenib
- Other product name
- S95032/AG-881 (10mg)
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- INSTITUT DE RECHERCHES INTERNATIONALES SERVIER (I.R.I.S)
- Paediatric formulation
- No
- Orphan designation
- No
Temozolomide Accord 180 mg hard capsules.
PRD3038515 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/10/615/033
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide Accord 100 mg hard capsules.
PRD3038511 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/10/615/029
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide Accord 250 mg hard capsules.
PRD3038517 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/10/615/035
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide Accord 20 mg hard capsules
PRD3501946 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/10/615/027
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide Accord 5 mg hard capsules.
PRD3038507 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/10/615/025
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide Accord 140 mg hard capsules.
PRD3038513 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/10/615/031
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
TEMOZOLOMIDE VIATRIS 180 mg, gélule
PRD11563968 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- 34009 269 968 8 8
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
TEMOZOLOMIDE VIATRIS 20 mg, gélule
PRD11563959 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- 34009 269 961 3 0
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
TEMOZOLOMIDE VIATRIS 250 mg, gélule
PRD11563971 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- 34009 269 970 2 1
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
TEMOZOLOMIDE VIATRIS 100 mg, gélule
PRD11563962 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- 34009 269 964 2 0
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
TEMOZOLOMIDE VIATRIS 5 mg, gélule
PRD11563955 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- 34009 269 958 2 9
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
TEMOZOLOMIDE VIATRIS 140 mg, gélule
PRD11563965 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- 34009 269 966 5 9
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide SUN 5 mg hard capsules
PRD3486939 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/013
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide SUN 20 mg hard capsules
PRD3490532 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/015
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide SUN 250 mg hard capsules
PRD3491345 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/023
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide SUN 140 mg hard capsules
PRD3490835 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/019
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide SUN 180 mg hard capsules
PRD3491076 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/021
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Temozolomide SUN 100 mg hard capsules
PRD3490693 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/017
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Recherches Internationales Servier IRIS
- Sponsor organisation
- Institut De Recherches Internationales Servier IRIS
- Address
- 22 Route 128
- City
- Gif Sur Yvette
- Postcode
- 91190
- Country
- France
Scientific contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Clinical Studies Department
Public contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Clinical Studies Department
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Ppd Inc. ORG-100018960
|
Middleton, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Other |
| Eurofins Adme Bioanalyses ORG-100034510
|
Vergeze, France | Other |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| Median Technologies ORG-100041462
|
Valbonne, France | Other |
| Cardiabase ORG-100043354
|
Nancy, France | Other |
| Firalis ORG-100027383
|
Huningue, France | Other |
| Eurofins Central Laboratory B.V. ORG-100036990
|
Breda, Netherlands | Other |
Locations
6 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 1 | 1 |
| France | Ongoing, recruitment ended | 3 | 3 |
| Germany | Ongoing, recruitment ended | 4 | 3 |
| Italy | Ongoing, recruitment ended | 4 | 3 |
| Netherlands | Ongoing, recruitment ended | 1 | 1 |
| Spain | Ongoing, recruitment ended | 4 | 2 |
| Rest of world
United States, Israel, China, United Kingdom, Japan
|
— | 33 | — |
Investigational sites
Medical University Of Vienna
Division of Oncology, Department of Medicine I, Waehringer Guertel 18-20, Alsergrund, Vienna
Assistance Publique Hopitaux De Paris
Service de neurologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Hospices Civils De Lyon
Service de neuro-oncologie, 59 Boulevard Pinel, 69500, Bron
Oncopole Claudius Regaud
Oncologie Médicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik für Neurologie-NeuroOnkologie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Heidelberg AöR
Department of Neurooncology, Center of Neurology, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Heidelberg University
Department of Neurology, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Istituto Oncologico Veneto
Department of Oncology, Oncology 1, Via Gattamelata 64, 35128, Padova
Humanitas Mirasole S.p.A.
Phase I and Neuroncology, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department of Neuroscience 'Rita Levi Montalcini', Via Cherasco 15, 10126, Turin
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Neurology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-05-23 | 2025-11-25 | |||
| France | 2025-04-22 | 2025-06-10 | 2025-11-25 | ||
| Germany | 2025-03-18 | 2025-07-29 | 2025-11-25 | ||
| Italy | 2025-04-02 | 2025-06-10 | 2025-11-25 | ||
| Netherlands | 2025-04-01 | 2025-05-23 | 2025-11-25 | ||
| Spain | 2025-03-21 | 2025-06-11 | 2025-11-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 42 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-513738-39-00_FP | 3.0 |
| Protocol (for publication) | D1_Protocol_Administrative Part_2024-513738-39-00_FP | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Consent_FRA | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements and informed consent Procedure_IT-en | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NLD | 2.0 |
| Subject information and informed consent form (for publication) | L1_Adult Participant ICF_Phase II_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Partner_en_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Adult participant_FRA_public | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_IT-it_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Main_IT-it_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult_NLD redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_en_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ESP_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Analysis_Adult_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ESP_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_NLD_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Informed Consent Form_Genetic tests_FRA_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Informed Consent Form_Pregnant Partner_FRA_public | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card_IT-it | NA |
| Subject information and informed consent form (for publication) | L2_Pregnant Partner_Pregnant Patient_ICF_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L3_Centre-Specific Contact Data List | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_EU SmPC_Temodal as RSI | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_EU SmPC_Temodal as RSI | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_EU SmPC_Temodal as RSI | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_EU SmPC_Temodal as RSI | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis AT_2024-513738-39-00_German_FP | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis DE_2024-513738-39-00_German_FP | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis ES_2024-513738-39-00_Spanish_FP | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis FR_2024-513738-39-00_French_FP | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis IT_2024-513738-39-00_Italian_FP | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis NL_2024-513738-39-00_Dutch_FP | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis_2024-513738-39-00_English_FP | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis AUT_2024-513738-39-00_German_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR_2024-513738-39-00_French_FP | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT_2024-513738-39-00_Italian_FP | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NED_2024-513738-39-00_Dutch_FP | 2.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SPN_2024-513738-39-00_Spanish_FP | 2.2 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-22 | Netherlands | Acceptable 2025-02-24
|
2025-02-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-28 | Acceptable | 2025-03-21 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-01 | Netherlands | Acceptable | 2025-07-01 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-04 | Acceptable | 2025-08-04 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-08-25 | Netherlands | Acceptable | 2025-08-25 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-13 | Netherlands | Acceptable 2025-12-09
|
2025-12-09 |