NCT04319276

Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

A Phase 1 Clinical Trial of Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 investigational study to assess the safety and preliminary efficacy of oral gallium maltolate (GaM) in participants with relapsed glioblastoma (GBM).

Detailed description

This is a prospective, single-center, single-arm, open-label phase 1 study to determine the antineoplastic activity, safety and tolerance of GaM in participants with relapsed, treatment-refractory GBM. Although GaM has been studied in previous phase 1 clinical trials in normal individuals and in participants with a variety of different solid tumors, it has never been evaluated in this population of participants. Dosages in this study have been defined to have limited side effects in other phase 1 trials. The maximum number of participants to enroll in the dose escalation part will not exceed 36. The trial will follow a 3 + 3 phase I dose escalation design.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Gallium maltolate (500 mg)	This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily; level 3: 2,000 mg daily; level 4: 2,500 mg daily.
DRUG	Gallium maltolate (1,000 mg)	This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily; level 3: 2,000 mg daily; level 4: 2,500 mg daily.
DRUG	Gallium maltolate (1,500 mg)	This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily; level 3: 2,000 mg daily; level 4: 2,500 mg daily.
DRUG	Gallium maltolate (2,000 mg)	This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily; level 3: 2,000 mg daily; level 4: 2,500 mg daily.
DRUG	Gallium maltolate (2,500 mg)	This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily; level 3: 2,000 mg daily; level 4: 2,500 mg daily.
DRUG	Gallium maltolate (recommended phase 2 dose)	The maximum-tolerated dose (recommended phase 2 dose).

Timeline

• Start date: 2022-11-11
• Primary completion: 2025-02-13
• Completion: 2027-03-01
• First posted: 2020-03-24
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study