NCT04319276View on ClinicalTrials.gov

Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

PHASE1Active, not recruitingINTERVENTIONAL

Enrollment

26

Participants

Timeline

Start Date

November 11, 2022

Primary Completion Date

February 13, 2025

Study Completion Date

October 10, 2025

Conditions

Glioblastoma

Interventions

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).

Trial Locations (1)

53226

Froedtert Hospital & the Medical College of Wisconsin, Milwaukee

All Listed Sponsors

lead

Medical College of Wisconsin

OTHER