Clinical trial • Phase I | Phase III • Oncology

Gemcitabine for Recurrent glioblastoma | Glioblastoma multiforme

Phase I | Phase III trial of Gemcitabine for Recurrent glioblastoma | Glioblastoma multiforme. None/Not specified-controlled. 15 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Recurrent glioblastoma | Glioblastoma multiforme
Trial Stage
Phase I | Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
02-10-2024
First CTIS Authorization Date
22-10-2024

Trial design

None/Not specified-controlled Phase I | Phase III trial across 1 site in Norway.

Comparator
None/Not specified
Target Sample Size
15

Eligibility

Recruits 15 No vulnerable populations selected. Informed consent must be signed by patients according to ICH GCP and national/local regulations. Subject information and informed consent form documents are provided for adults..

Vulnerable Population
No vulnerable populations selected. Informed consent must be signed by patients according to ICH GCP and national/local regulations. Subject information and informed consent form documents are provided for adults.

Inclusion criteria

  • {"criterion_text":"- Histologically verified glioblastoma\n- Must be ambulatory with an ECOG performance status 0-1\n- Must be 18 to 70 years of age.\n- Adequate bone marrow, liver and heart function\n- 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

  • {"criterion_text":"- Patients taking part in other clinical trials which could make incusion or follow-up difficult\n- Any reason why, in the opinion of the investigator, the patient should not participate."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Ability to perform drug-screen and select possible treatment strategy","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Tumor volume ccording to response assessment in neuro-oncology (RANO) criteria","definition_or_measurement_approach":"Measured according to the updated Response Assessment in Neuro‑Oncology (RANO) criteria."}
  • {"endpoint_text":"- Adverse events induced by selected treatments","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall survival in treated patients","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Comparsion of drug response to individual molecular fingerprint of drug selectivity.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
15
Recruitment Window Months
120
Consent Approach
Signed informed consent required from patients according to ICH GCP and national/local regulations. Subject information and informed consent form (ICF) documents are provided for adults.

Geography

Total Number Of Sites
1
Total Number Of Participants
15

Norway

Earliest CTIS Part Ii Submission Date
12-10-2024
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
499
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
Oslo University Hospital HF
Department Name
Department of Neurosurgery
Principal Investigator Name
Einar Osland Vik-Mo
Principal Investigator Email
uxvieb@rr-research.no
Contact Person Name
Einar Osland Vik-Mo
Contact Person Email
uxvieb@rr-research.no
Number Of Participants
15

Sponsor

Primary sponsor

Full Name
Oslo University Hospital HF
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Norway

Investigational products

Investigational Product Name
Gemcitabine Accord 100 mg/ml konsentrat til infusjonsvæske
Active Substance
Gemcitabine
Modality
Small molecule
Routes Of Administration
Infusion
Route
Infusion
Authorisation Status
Authorised (marketing authorisation number 10-8088)
Maximum Dose
1320 mg/m2 (max daily); 3960 mg/m2 (max total)
Combination Treatment
Yes

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