Bioavailability of Disulfiram and Metformin in Glioblastomas (INSIDE)
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|ClinicalTrials.gov Identifier: NCT03151772|
Recruitment Status : Terminated (Problems with including patients)
First Posted : May 12, 2017
Last Update Posted : September 28, 2020
Neuro-oncological trials may fail due to the drug never getting to the intended target (i.e. within the tumor micro environment). Also, changes' occurring in tumor cells when removed from patients and grown in-vitro is another limiting factor influencing the clinical success.
Important questions are therefore:
- Does the drug get there?
- Does the drug do what it is intended to do?
To improve chances of clinical success there is a need for rational and intelligent selection of potential drugs in future trials. This is an initiative for analyzing tumor concentration of preoperative administered repurposed drugs
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Disulfiram Drug: Metformin||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Bioavailability study with an adaptive design (evaluation after 5 patients up to a total maximum of 20 patients in each arm). Experimental therapy not to be combined and not any comparison between therapies|
|Masking:||None (Open Label)|
|Official Title:||Drug Level and Investigation of Novel Substances Indicated Downstream Effect in Glioblastoma|
|Actual Study Start Date :||January 29, 2018|
|Actual Primary Completion Date :||September 24, 2020|
|Actual Study Completion Date :||September 24, 2020|
Disulfiram 200 mg twice daily and copper 2,5 mg once daily. For bioavailability purpose only, treatment is withdrawn postoperatively
200 mg disulfiram two times daily and 2,5 mg copper once daily taken preoperatively
Metformin 850 mg x 3 daily. For bioavailability purpose only, treatment is withdrawn postoperatively
Metformin 850 mg x 3 taken preoperatively
- Bioavailabilty disulfiram [ Time Frame: At time of surgery ]Concentration of disulifram-copper complex available in glioblastoma compared to blood
- Bioavailabilty of metformin [ Time Frame: At time of surgery ]Concentration of metformin available in glioblastoma compared to blood
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151772
|Sahlgrenska University Hospital|
|Principal Investigator:||Asgeir S Jakola, MD, PhD||Sahlgrenska University Hospital, Sweden|