A Phase 2, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating LSTA1 when added to standard of care (temozolomide) versus temozolomide and matching LSTA1 placebo in subjects with newly diagnosed Glioblastoma Multiforme (GBM)

Conditions

Glioblastoma Multiforme

Brief summary

Overall survival: Median time from randomization until death due to any cause

Detailed description

12-month survival, 24-month survival, Median progression-free survival (PFS) based on RANO criteria PFS at 6 months, Median progression-free survival (PFS) based on RANO criteria PFS at 12 months, ORR: the number of patients with documented partial or complete response (PR or CR) based on RANO criteria, relative to the screening tumor measurement, divided by the number of patients evaluable for response., Disease control rate, Duration of response (DOR) for a subset of responding patients with measurable disease at baseline, Scores on EORTC QLQ-30

Truusalu JP, Oselin K, Lass J, Buck KK, Sietsema W, Soeorg H, Toome K, Kaarna K, Teesalu T, Kõrgvee LT.

2025-11-13

10.1136/bmjopen-2025-106094

Interventions

DRUGTemozolomide Accord 100 mg hard capsules.

DRUGPlacebo

DRUGLSTA1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival: Median time from randomization until death due to any cause	—

Secondary

Measure	Time frame
12-month survival, 24-month survival, Median progression-free survival (PFS) based on RANO criteria PFS at 6 months, Median progression-free survival (PFS) based on RANO criteria PFS at 12 months, ORR: the number of patients with documented partial or complete response (PR or CR) based on RANO criteria, relative to the screening tumor measurement, divided by the number of patients evaluable for response., Disease control rate, Duration of response (DOR) for a subset of responding patients with measurable disease at baseline, Scores on EORTC QLQ-30	—

Measure

Time frame

12-month survival, 24-month survival, Median progression-free survival (PFS) based on RANO criteria PFS at 6 months, Median progression-free survival (PFS) based on RANO criteria PFS at 12 months, ORR: the number of patients with documented partial or complete response (PR or CR) based on RANO criteria, relative to the screening tumor measurement, divided by the number of patients evaluable for response., Disease control rate, Duration of response (DOR) for a subset of responding patients with measurable disease at baseline, Scores on EORTC QLQ-30

—

Countries

Estonia, Latvia, Lithuania

Outcome results

None listed