drugset / Trial / NCT04250922
LAM561 With RT and TMZ for Adults With Glioblastoma
Phase 2/3
Active not recruiting
144 enrolled
Laminar Pharmaceuticals
LIPODOM THERAPEUTICS · collabLaboratory Corporation of America · collabNorthern Institute for Cancer Research, Newcastle · collabTheradis pharma · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The proposed Phase IIB/III randomized, double-blind, placebo-controlled trial in subjects with newly diagnosed primary glioblastoma multiforme (ndGBM) aims to compare the efficacy and safety of LAM561 versus placebo, given with standard of care (SoC) therapy of radiation therapy plus temozolomide (TMZ), followed by an adjuvant treatment of 6 month period of TMZ and then LAM561 or placebo in monotherapy.
Timeline
- Start
- 2019-12-01
- Primary completion
- 2026-01-15
- Completion
- 2026-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LAM561 | Small molecule | 12 g | Oral |
| Background | Temozolomide | Small molecule | 75 mg/m2 | Oral |
| Background | Temozolomide | Small molecule | 150 mg/m2 | Oral |
| Background | Temozolomide | Small molecule | 200 mg/m2 | Oral |