Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients (NCT06095375) | Clinical Trial Compass
CompletedPhase 1
Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients
Italy21 participantsStarted 2022-07-04
Plain-language summary
This study will evaluate the addition of regorafenib to standard of care treatment with TMZ as adjuvant therapy, and in combination with TMZ+RT as concomitant therapy.
The standard of care for newly diagnosed GBM (ndGBM) includes surgical resection to the extent that is safely feasible, followed by RT plus concomitant TMZ chemotherapy, and up to 6 months of adjuvant TMZ.
The dose escalation will be explored following a "3+3" design, escalating oral doses of regorafenib in combination with adjuvant (maintenance) TMZ (cohort A) to estimate the MTD of regorafenib as adjuvant (maintenance) therapy. After finding the MTD in the Adjuvant Therapy dose escalation, the Concomitant Therapy (cohort B) dose escalation will start, exploring escalating oral doses of regorafenib in combination with concomitant TMZ+RT, to estimate the MTD of regorafenib as concomitant therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. All AEs resulting from prior RT+TMZ chemotherapy must have resolved to NCI CTCAE (v5.0) Grade 1 (except for laboratory parameters outlined below).
✓. Subject must have not experienced significant toxicity to prior RT+TMZ (i.e., Grade 4 hematological toxicity)
✓. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if subject received pegfilgrastim).
✓. Hemoglobin (Hgb) ≥10 g/dL
✓. Platelet count (plt) ≥100x 109/L
✓. Serum potassium concentration within normal range, or correctable with supplements
✓. Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamate pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ≤ 3.0 x Upper Limit of Normal (ULN).
✓. Serum total bilirubin ≤ 1.5 x ULN
Exclusion criteria
✕. Prior prolifeprospan 20 with carmustine wafer.
What they're measuring
1
Number of patients with a Dose Limiting Toxicity (DLT)
Timeframe: During dose escalation, the DLT evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days)
2
Number of patients with ≥1 adverse event (AE) using the NCI CTCAE v5.0
Timeframe: evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days)
3
Number of patients discontinuing study treatment due to an AE
Timeframe: evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days)
✕. Prior radiation treatment for GBM or lower-grade glioma.
✕. Prior chemotherapy or immunotherapy for GBM or lower-grade glioma.
✕. NOTE: 5-aminolevulinic acid-mediated photodynamic therapy and Flourcrescein administered prior to surgery to aid in optimal surgical resection is not considered a chemotherapy agent.