Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
116
Countries
1
Sites
6
Glioblastoma
Phase 1 Arms A and B/C: To characterize the safety and tolerability of Debio 0123 combined with TMZ (Arm A) and with TMZ and RT (Arm B and C) and to select the Debio 0123 doses for further investigation. Phase 1 Dose expansion: To identify the RD of Debio 0123 combined with TMZ for further development. Phase 2: To a…
Key facts
- Sponsor
- Debiopharm International S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 May 2023 → ongoing
- Decision date (initial)
- 2023-04-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Debiopharm International S.A.
External identifiers
- EU CT number
- 2022-502156-31-00
- WHO UTN
- U1111-1283-6423
- ClinicalTrials.gov
- NCT05765812
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacokinetic, Efficacy, Safety, Others, Pharmacodynamic
Phase 1 Arms A and B/C: To characterize the safety and tolerability of Debio 0123 combined with TMZ (Arm A) and with TMZ and RT (Arm B and C) and to select the Debio 0123 doses for further investigation.
Phase 1 Dose expansion: To identify the RD of Debio 0123 combined with TMZ for further development.
Phase 2: To assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ, compared to the standard of care.
Secondary objectives 13
- Phase 1 – Arm A: To determine the pharmacokinetics (PK) of Debio 0123 and of its metabolite in plasma in combination with TMZ.
- Phase 1 – Arm A: To determine the PK of TMZ in plasma in combination with Debio 0123.
- Phase 1 – Arm A: To investigate preliminary antitumor activity of Debio 0123 when administered in combination with TMZ.
- Phase 1 – Arm B/C: To determine the PK of Debio 0123 and of its metabolite in plasma in combination with TMZ and RT.
- Phase 1 – Arm B/C: To determine the PK of TMZ in combination with Debio 0123 and RT.
- Phase 1 – Arm B/C: To investigate preliminary antitumor activity of Debio 0123 when administered in combination with TMZ and RT.
- Phase 1 dose expansion: To confirm the PK of Debio 0123 and of its metabolite in plasma in combination with TMZ.
- Phase 1 dose expansion: To confirm the PK of Debio 0123 and of its metabolite in plasma in combination with TMZ.
- Phase 1 dose expansion: To investigate preliminary efficacy of Debio 0123 when administered in combination with TMZ .
- Phase 1 dose expansion: To investigate preliminary antitumor activity of Debio 0123 when administered in combination with TMZ
- Phase 2: To assess the antitumor activity of Debio 0123 when administered in combination with TMZ compared to standard of care.
- Phase 2: To characterize the safety and tolerability of Debio 0123 when administered in combination with TMZ, compared to standard of care.
- Phase 2: To confirm the PK of Debio 0123 and of its metabolite in plasma in combination with TMZ.
Conditions and MedDRA coding
Glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 17
- Phase 1 and Phase 2 Signed written informed consent approved before undertaking any study-specific procedures.
- Phase 1 and Phase 2 Age ≥18 years of age.
- Phase 1 and Phase 2 Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.
- Phase 1 and Phase 2 Adequate bone marrow, hepatic, and renal function
- Phase 1 and Phase 2 Life expectancy of at least 3 months in the best judgment of the Investigator
- Phase 1 and Phase 2 Participants receiving corticosteroids must be on a stable or decreasing dose of ≤4 mg daily dexamethasone (or ≤25 mg prednisone) for the 7 days prior to the start of study treatment.
- Phase 1 and Phase 2 Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.
- Phase 1 and Phase 2 Measurable or non-measurable disease per RANO criteria by gadolinium (Gd)-based contrast-enhanced brain magnetic resonance imaging (MRI).
- Phase 1 and Phase 2 Willing to practice highly effective methods of contraception.
- Phase 1 and Phase 2 Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Additional specific criteria for Phase 1 Arm A Participants must have one of the following histopathologically proven diagnoses (WHO 2021) • GBM IDH-wildtype, Grade 4, which may include secondary GBMs (i.e., those that progress from low-grade gliomas) • Astrocytoma, IDH-mutant, Grade 3
- Additional specific criteria for Phase 1 Arm B/C: Participants must have a new, histopathologically proven diagnosis (WHO 2021) of GBM, IDH-wildtype, Grade 4, which may include secondary GBMs (i.e., those that progress from low-grade gliomas).
- Additional specific criteria for Phase 1 Arm A/dose expansion and Phase 2 A maximum of 1 (Phase 1 dose expansion and Phase 2) or 2 (Phase 1 Arm A) prior treatment lines of which first-line must be treatment with TMZ-based chemoradiotherapy (TMZ concomitantly with RT)
- Additional specific criteria for Phase 1 Arm A/dose expansion and Phase 2 Documented disease recurrence or progression by diagnostic biopsy or Gd-based contrast-enhanced brain MRI as per RANO criteria.
- Additional specific criteria for Phase 1 Arm A/dose expansion and Phase 2 C) KPS ≥60.
- Additional specific criteria for Phase 1 Arm B/C B) KPS ≥70.
- Additional specific criteria for Phase 1 dose expansion and Phase 2 Participants must have a histopathologically proven diagnosis (WHO 2021) of GBM, IDH-wildtype, Grade 4.
Exclusion criteria 12
- Phase 1 and Phase 2 History of other malignancies requiring active treatment in the last 2 years prior to the first dose of study treatment except for superficial bladder cancers, adequately treated low-risk prostate cancer under active surveillance, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent.
- Specific criteria for Phase 1 Arm A Prior TMZ-related hematological event leading to discontinuation of TMZ during the concurrent chemoradiotherapy.
- Additional specific criteria for Phase 1 Arm B/C Prior radiation, chemotherapy, biological therapy, interstitial brachytherapy, implanted chemotherapy, therapeutics delivered by local injection or convection-enhanced delivery for GBM.
- Specific criteria for Phase 1 Arm B/C Prior therapy that would result in an overlap of the radiation fields.
- Additional specific criteria for Phase 1 dose expansion and Phase 2 Prior treatment with more than 1 line of systemic therapy for GBM, IDH-wildtype, Grade 4. Combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1systemic line
- Phase 1 and Phase 2 Known contraindication for Gd-based, contrast-enhanced MRI.
- Phase 1 and Phase 2 Left ventricular ejection fraction (LVEF) below 55%.
- Phase 1 and Phase 2 Chemotherapy, monoclonal antibodies/biologics, investigational treatment, or RT with curative intent within 28 days prior to starting study treatment.
- Phase 1 and Phase 2 Hypersensitivity to Debio 0123, TMZ, dacarbazine, or any of the excipients found in the formulation for Debio 0123 or TMZ
- Phase 1 and Phase 2 Prior exposure to any WEE1 inhibitor
- Additional specific criteria for Phase 1 Arm A Prior treatment with more than 2 lines of therapy for GBM IDH-wildtype, Grade 4, or for astrocytoma, IDH-mutant, Grade 3.
- Specific criteria for Phase 1 Arm A Prior treatment with bevacizumab or with other vascular endothelial growth factor (VEGF) inhibitors or VEGF-receptor signaling inhibitors.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 10
- Phase 1 (Arms A and B/C): Occurrence of Drug Limiting Toxicities
- Phase 1 (Arms A and B/C): Occurrence and severity of TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs leading to treatment discontinuation and/or dose modifications, graded according to NCI-CTCAE
- Phase 1 (Arms A and B/C): Laboratory parameters and related severity based on NCI-CTCAE
- Phase 1 (Arms A and B): Occurrence of treatment discontinuations and treatment modifications due to TEAEs and laboratory abnormalities
- Phase 1 (Arms A and B/C): Changes from baseline in parameters of vital signs, ECG, echocardiogram, and KPS
- Phase 1 – dose expansion: Occurrence and severity of TEAEs graded according to NCI- CTCAE 5.0
- Phase 1 – dose expansion: OR as per RANO and change from baseline in tumor size
- Phase 1 – dose expansion: PDy (change from baseline in pCDC2)
- Phase 1 – dose expansion: Plasma exposure of Debio 0123 and its metabolite
- Phase 2: Overall Survival
Secondary endpoints 13
- Phase 1 - Arm A: PK profile and PK parameters of Debio 0123 and its metabolite after repeated dosing including but not limited to: Cmax, Ctrough, tmax, AUClast.
- Phase 1 - Arm A: PK profile and parameters of TMZ after repeated dosing, including but not limited to: Cmax, AUClast, Ctrough.
- Phase 1 (Arm A, B/C and dose expansion) and Phase 2: Tumor response according to the RANO criteria: BOR, OR, DC.
- Phase 1 (Arm A, B/C and dose expansion) and Phase 2: DOR and PFS according to RANO criteria.
- Phase 1 - Arm B/C: PK profile and PK parameters of Debio 0123 and its metabolite after repeated dosing, including but not limited to: Cmax, Ctrough, tmax, AUClast.
- Phase 1 - Arm B/C: PK profile and parameters of TMZ, including but not limited to: Cmax, AUClast, Ctrough.
- Phase 1 dose expansion and phase 2: Occurrence and severity of TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs leading to treatment discontinuation and/or dose modifications, graded according to NCI-CTCAE.
- Phase 1 dose expansion and phase 2: Laboratory parameters and related severity based on NCI-CTCAE 5.0
- Phase 1 dose expansion and phase 2: Occurrence of treatment discontinuations and treatment modifications due to TEAEs and laboratory abnormalities.
- Phase 1 dose expansion and phase 2: Changes from baseline in parameters of vital signs, ECG, echocardiogram, and KPS.
- Phase 1 dose expansion: PK parameters of Debio 0123 and its metabolite, including but not limited to Ctrough and AUC
- Phase 1 dose expansion: Overall Survival
- Phase 2: PK parameters of Debio 0123 and its metabolite as applicable, including but not limited to: Ctrough and AUC
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 29
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Temozolomide SUN 5 mg hard capsules
PRD9229443 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- PLGB 31750/0167
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
Temozolomide SUN 250 mg hard capsules
PRD3491344 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/024
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
Temozolomide SUN 180 mg hard capsules
PRD3491079 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/022
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
Temozolomide SUN 180 mg hard capsules
PRD9229446 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- PLGB 31750/0171
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
Temozolomide SUN 20 mg hard capsules
PRD9229448 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- PLGB 31750/0168
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
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
- Packaging: Overlabelling and Re-sealing
Temozolomide SUN 140 mg hard capsules
PRD3490836 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/020
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
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
- Packaging: Overlabelling and Re-sealing
Temozolomide SUN 140 mg hard capsules
PRD9229447 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- PLGB 31750/0170
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
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
- Packaging: Overlabelling and Re-sealing
Temozolomide SUN 5 mg hard capsules
PRD3486941 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/014
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
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
- Packaging: Overlabelling and Re-sealing
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
- Packaging: Overlabelling and Re-sealing
Temozolomide SUN 100 mg hard capsules
PRD9229444 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- PLGB 31750/0169
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
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
- Packaging: Overlabelling and Re-sealing
Temozolomide SUN 20 mg hard capsules
PRD3490534 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/016
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
Temozolomide SUN 100 mg hard capsules
PRD3490691 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/11/697/018
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging: Overlabelling and Re-sealing
PRD10560958 · Product
- Active substance
- 3-26-DICHLOROPHENYL-23-DIHYDRO-1-METHYL-7-3-METHYL-4-1-METHYL-4-PIPERIDINYLPHENYLAMINO-PYRIMIDO45-DPYRIMIDIN-41H-ONE
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- DEBIOPHARM
- Paediatric formulation
- No
- Orphan designation
- No
PRD10560955 · Product
- Active substance
- 3-26-DICHLOROPHENYL-23-DIHYDRO-1-METHYL-7-3-METHYL-4-1-METHYL-4-PIPERIDINYLPHENYLAMINO-PYRIMIDO45-DPYRIMIDIN-41H-ONE
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- DEBIOPHARM
- Paediatric formulation
- No
- Orphan designation
- No
PRD10560954 · Product
- Active substance
- 3-26-DICHLOROPHENYL-23-DIHYDRO-1-METHYL-7-3-METHYL-4-1-METHYL-4-PIPERIDINYLPHENYLAMINO-PYRIMIDO45-DPYRIMIDIN-41H-ONE
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- DEBIOPHARM
- Paediatric formulation
- No
- Orphan designation
- No
PRD10060164 · Product
- Active substance
- 3-26-DICHLOROPHENYL-23-DIHYDRO-1-METHYL-7-3-METHYL-4-1-METHYL-4-PIPERIDINYLPHENYLAMINO-PYRIMIDO45-DPYRIMIDIN-41H-ONE
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- DEBIOPHARM
- Paediatric formulation
- No
- Orphan designation
- No
PRD10560956 · Product
- Active substance
- 3-26-DICHLOROPHENYL-23-DIHYDRO-1-METHYL-7-3-METHYL-4-1-METHYL-4-PIPERIDINYLPHENYLAMINO-PYRIMIDO45-DPYRIMIDIN-41H-ONE
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- DEBIOPHARM
- Paediatric formulation
- No
- Orphan designation
- No
PRD10560957 · Product
- Active substance
- 3-26-DICHLOROPHENYL-23-DIHYDRO-1-METHYL-7-3-METHYL-4-1-METHYL-4-PIPERIDINYLPHENYLAMINO-PYRIMIDO45-DPYRIMIDIN-41H-ONE
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- DEBIOPHARM
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
SCP5489548 · ATC
- Active substance
- Bromhexine Hydrochloride
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Debiopharm International S.A.
- Sponsor organisation
- Debiopharm International S.A.
- Address
- Chemin Messidor 5-7
- City
- Lausanne
- Postcode
- 1006
- Country
- Switzerland
Scientific contact point
- Organisation
- Debiopharm International S.A.
- Contact name
- Debiopharm International S.A / Clinical department
Public contact point
- Organisation
- Debiopharm International S.A.
- Contact name
- Debiopharm International S.A / Clinical department
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| SGS Analytics Switzerland AG ORG-100016268
|
Birsfelden, Switzerland | Laboratory analysis |
| 4G Clinical B.V. ORG-100044721
|
Amsterdam, Netherlands | Interactive response technologies (IRT) |
| SGS Belgium ORG-100007917
|
Mechelen, Belgium | Code 10, Other, Data management, Code 8 |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Code 10 |
| Medpace Finland Oy ORG-100009147
|
Helsinki, Finland | On site monitoring, Code 12, Other, Other, Code 2, Laboratory analysis, Code 5, E-data capture |
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 55 | 6 |
| Rest of world
Switzerland, United States
|
— | 61 | — |
Investigational sites
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
University Clinic Of Navarra
Neurology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Donostia
Oncology, Pasealeku Doct. Begiristain 109, 20014, Donostia
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 |
|---|---|---|---|---|---|
| Spain | 2023-05-26 | 2023-07-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 29 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol - Extract (for publication) | D1_Protocol clarification letter_2022-502156-31_Debiopharm_redacted | N/A |
| Protocol (for publication) | D1_Protocol amendment_2022-502156-31_Debiopharm_redacted | 3 |
| Protocol (for publication) | D1_Protocol clarification letter_2022-502156-31_Debiopharm_redacted | N/A |
| Protocol (for publication) | D1_Protocol_2022-502156-31_redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_ePRO screenshots_EN_Debiopharm_blank | N/A |
| Protocol (for publication) | D4_Patient facing documents_ePRO screenshots_ES_Debiopharm_blank | N/A |
| Protocol (for publication) | D4_Patient facing documents_PRO_EN_Debiopharm_blank | N/A |
| Protocol (for publication) | D4_Patient facing documents_PRO_ES_Debiopharm_blank | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Spain | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Debiopharm | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DearColleagueLetter_Debiopharm | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantJourney ArmA_Debiopharm | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantJourney ArmB | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantJourney ArmC_Debiopharm | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantJourney Dose Expansion_Debiopharm | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Arm A_Debiopharm_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Arm B | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Arm C_Debiopharm_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Dose Expansion_Debiopharm_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PCS ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP ICF Arm A_Debiopharm | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP ICF Arm B | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP ICF Arm C_ Debiopharm | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP ICF Dose Expansion_Debiopharm | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard EC Overview | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Document cross referring to EU SmPC for Temozolomide | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Temozolomide_EU | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_English_2022-502156-31_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Spanish_2022-502156-31_redacted | 5.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-31 | Spain | Acceptable 2023-04-26
|
2023-04-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-08 | Spain | Acceptable with conditions 2023-11-13
|
2023-11-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-30 | Spain | Acceptable 2024-02-22
|
2024-02-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-30 | Spain | Acceptable 2024-07-10
|
2024-07-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-08-28 | Spain | Acceptable 2024-10-11
|
2024-10-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-10-23 | Spain | Acceptable | 2024-10-31 |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-01-14 | Spain | Acceptable 2025-02-19
|
2025-02-19 |
| 8 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-08-06 | Spain | Acceptable 2025-09-22
|
2025-09-25 |
| 9 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-09-26 | Spain | Acceptable | 2025-11-03 |