Metformin And Chloroquine in IDH1/2-mutated Solid Tumors (NCT02496741) | Clinical Trial Compass
CompletedPhase 1/2
Metformin And Chloroquine in IDH1/2-mutated Solid Tumors
Netherlands15 participantsStarted 2015-11
Plain-language summary
This phase Ib, open-label, single-center, non-randomized clinical trial will evaluate the toxicity and efficacy of metformin and chloroquine in isocitrate dehydrogenase 1/2-mutated (IDH1/2MT) patients with a glioma, intrahepatic cholangiocarcinoma or chondrosarcoma.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Presence of a glioma, IHCC or WHO grade ≥ II CS (both newly-diagnosed and refractory/relapsed tumors)
✓. Tumor carries a neomorphic D-2HG generating mutation in IDH1 or IDH2 as determined by MS of serum and urine (optional: bile), MRS of the tumor or DNA sequencing of (circulating) tumor material.
✓. Measurable lesion according to RECIST 1.1 criteria (see Appendix B) in IHCC and CS patients and RANO criteria (see Appendix C) in glioma patients.
✓. ECOG/WHO performance 0-2 (see Appendix D).
✓. Age \> 18 years.
✓. Adequate renal function (creatinine \< 150 μmol/L and/ or a creatinine clearance \> 60 ml/ L).
✓. Adequate liver function (bilirubin \< 1.5 times upper limit of normal, ALAT or ASAT \< 5.0 times upper limit of normal in case of liver metastases and \< 2.5 the upper limit of normal in absence of liver metastases).
✓. Adequate bone marrow function (WBC \> 3.0 x 109/L, platelets \> 100 x 109/L).
Exclusion criteria
✕. Pregnancy (positive serum pregnancy test) and lactation.
✕. Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator.
✕. Patients who have any severe and/or uncontrolled medical conditions such as:
What they're measuring
1
Maximum tolerated dose of metformin + chloroquine
Timeframe: 1 year
Trial details
NCT IDNCT02496741
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
✕. Patients that use digoxin, MAO inhibitors, fenylbutazone, oxygenbutazone, gold preparations or cimetidine (known pharmaco interaction with chloroquine) or loop diuretics (known pharmaco interaction with metformin) for which no good alternative is available.
✕. Patients that have a known history of alcohol abuse (interaction with metformin).
✕. Patients with known glucose-6-phosphate dehydrogenase deficiency, porphyria, myasthenia gravis or ocular/retinal aberrations (interaction with chloroquine).
✕. Patients with a known hypersensitivity to metformin or chloroquine.