Overview
Sponsor-declared trial summary
Recurrent Glioblastoma
Establishment and feasability evaluation of high-throuhput drug screens of personalized tumor stem cell cultures. Success of generating an individualized treatment selection based on drug screening.
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Mar 2023 → ongoing
- Decision date (initial)
- 2024-10-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510214-11-00
- EudraCT number
- 2017-000052-26
- ClinicalTrials.gov
- NCT05043701
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Establishment and feasability evaluation of high-throuhput drug screens of personalized tumor stem cell cultures. Success of generating an individualized treatment selection based on drug screening.
Secondary objectives 4
- Tumor response by chosen drug combination according to the updated response assessment in neuro-oncology (RANO) criteria
- Adverse events induced by selected treatments
- Overall survival in treated patients
- Comparsion of drug response to individual molecular fingerprint of drug selectivity.
Conditions and MedDRA coding
Recurrent Glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018337 | Glioblastoma multiforme | 100000004864 |
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Histologically verified glioblastoma
- Must be ambulatory with an ECOG performance status 0-1
- Must be 18 to 70 years of age.
- Adequate bone marrow, liver and heart function
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
Exclusion criteria 2
- Patients taking part in other clinical trials which could make incusion or follow-up difficult
- Any reason why, in the opinion of the investigator, the patient should not participate.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Ability to perform drug-screen and select possible treatment strategy
Secondary endpoints 4
- Tumor volume ccording to response assessment in neuro-oncology (RANO) criteria
- Adverse events induced by selected treatments
- Overall survival in treated patients
- Comparsion of drug response to individual molecular fingerprint of drug selectivity.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Gemcitabine Accord 100 mg/ml konsentrat til infusjonsvæske
PRD1980155 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1320 mg/m2 milligram(s)/square meter
- Max total dose
- 3960 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 10-8088
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The IMP is used for Glioblastoma as per protocol
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Einar Vik-Mo
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Einar Vik-Mo
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Norway | 2023-03-21 | 2024-03-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2023-510214-11-00 | 5.0 |
| Protocol (for publication) | D1 Protocol 2023-510214-11-00 4-3 to 4-6 TRACK CHANGES | 5.0 |
| Protocol (for publication) | D1_Protocol SOC 2023-510214-11-00 | 5.0 |
| Recruitment arrangements (for publication) | K1_recruitment arrangement | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ADULTS | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ADULTS TC | 4.1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Gemcitabine | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NO 2023-510214-11-00 | 5.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-02 | Norway | Acceptable with conditions 2024-10-22
|
2024-10-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-04 | Norway | Acceptable 2026-02-23
|
2026-02-23 |