NCT03867123

A Study to Evaluate the Safety of LAM561 Added to Standard of Care in Newly-diagnosed Glioblastoma Patients

A Phase 1B Study of the Safety of LAM561 Administered Orally in Combination With Temozolomide (TMZ) and Radiation Therapy or With TMZ Alone in the First Line Treatment of Subjects With Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Laminar Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of LAM561 added to first-line treatment for subjects with newly diagnosed glioblastoma (GBM), and to determine the highest safe dose of LAM561 administered orally when added to the concurrent phase of treatment with temozolomide (TMZ) and radiation therapy (RT) or when added to the maintenance phase of treatment with TMZ (once TMZ 200 g/m2/day is started).

Detailed description

This is a Phase IB, open-label, dose-finding study. A de-escalation process has been selected for the study with a 3+3 design to establish the Maximum Tolerated Dose (MTD). The first group of 3 subjects (within each arm), where all 3 subjects may be started at the same time, will receive LAM561 at the starting dose of 12 g/day (4 g tid). If 0-1 Dose-Limiting Toxicities (DLTs) in the first 3 patients, then a new cohort with 3 more patients is started at 12 g/day (4 g tid). If 2 or more patients out of 3 or 6 patients experience DLT(s) the dose is deescalated. De-escalation doses are from 12 g/day (4 g tid) to 8 g/day (4 g bid) and from 8 g/day (4 g bid) to 4 g/day (4 g od). This procedure must be applied to the two arms of the study described below. Both arms will be independent, and will run in parallel, therefore none of the patients from Arm 1 may enter Arm 2.

Conditions

• Glioblastoma (GBM)

Interventions

Type	Name	Description
DRUG	LAM561	Arm 1: Daily for 6 weeks. Arm 2: daily, two 28-day cycles
RADIATION	RT	In Arm 1: Fractionated focal irradiation of 1.8-2 Gy/fraction/day, 5 days/week, 6 weeks. Total dose up to 60 Gy
DRUG	TMZ	Arm 1: 75 mg/m2/day, daily, 6 weeks Arm 2: 200 mg/m2/day, daily the first 5 days of two 28-day cycles (in case of toxicity, TMZ dose may be reduced to 150 mg/m2/day at Cycle 3 to allow for recovery)

Timeline

• Start date: 2018-12-04
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2019-03-07
• Last updated: 2023-02-21

Locations

3 sites across 1 country: Spain