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Metal Complex

Gallium Maltolate for Glioblastoma

Phase 1

Recruiting

Led By Jennifer Connelly, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female subjects must be ≥18 years of age.

Male subjects, even if surgically sterilized, must practice effective barrier contraception or true abstinence.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing a new drug to treat people with a certain type of brain cancer.

Who is the study for?

Adults diagnosed with relapsed glioblastoma who've completed standard treatments, including radiotherapy and temozolomide. They must have measurable disease or confirmed recurrence, be in fair health (ECOG 0-2), and have proper organ function. Women of childbearing potential and men must agree to contraception methods.Check my eligibility

What is being tested?

The trial is testing different doses of oral gallium maltolate for safety and initial effectiveness in treating recurrent glioblastoma. Participants will receive one of several dose levels, including a recommended phase 2 dose determined during the study.See study design

What are the potential side effects?

Specific side effects are not listed but may include typical reactions to oral medications such as gastrointestinal discomfort, potential liver or kidney issues based on required organ function tests, and possible interactions with iron supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a man and will use effective contraception or practice abstinence.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer's progress can be measured or has been confirmed through tests.

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I have been diagnosed with GBM or my tumor has GBM-like features according to WHO standards.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum-tolerated dose.

Secondary outcome measures

Dose-limiting toxicity

Overall survival

Progression-free survival

Trial Design

6Treatment groups

Experimental Treatment

Group I: Dose-expansion PhaseExperimental Treatment1 Intervention

A minimum of six participants will be enrolled in the dose expansion phase for a total of 12 subjects at the recommended phase 2 dose.

Group II: Dose-escalation Phase (500 mg)Experimental Treatment1 Intervention

This is a 3 + 3 design. Participants will be entered sequentially. If 0 of 3 participants has a dose-limiting toxicity (DLT), new participants may be entered at the next higher dose level. If 1 of 3 participants has a DLT, up to 3 more participants are to be treated at that same dose level. If 0 of the additional 3 participants at that dose level has a DLT, new participants may be entered at the next higher dose level. If 1 or more of the additional 3 participants experience a DLT, 0 participants are to be started at that dose level and the preceding dose is the maximum-tolerated dose (MTD). If 2 of 3 of the dosed participants has a DLT on the first dose level, the drug will be administered at a lower dose. If 0 of 3 participants has a DLT at the highest dose level, an additional 3 participants will be enrolled to ensure that 6 participants are treated at the MTD. The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a DLT.

Group III: Dose-escalation Phase (2,500 mg)Experimental Treatment1 Intervention

Group IV: Dose-escalation Phase (2,000 mg)Experimental Treatment1 Intervention

Group V: Dose-escalation Phase (1,500 mg)Experimental Treatment1 Intervention

Group VI: Dose-escalation Phase (1,000 mg)Experimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,547 Total Patients Enrolled

3 Trials studying Glioblastoma

118 Patients Enrolled for Glioblastoma

Jennifer Connelly, MDPrincipal InvestigatorMedical College of Wisconsin

1 Previous Clinical Trials

60 Total Patients Enrolled

1 Trials studying Glioblastoma

60 Patients Enrolled for Glioblastoma

Media Library

Gallium maltolate (Metal Complex) Clinical Trial Eligibility Overview. Trial Name: NCT04319276 — Phase 1

Glioblastoma Research Study Groups: Dose-escalation Phase (2,500 mg), Dose-escalation Phase (2,000 mg), Dose-escalation Phase (500 mg), Dose-escalation Phase (1,000 mg), Dose-escalation Phase (1,500 mg), Dose-expansion Phase

Glioblastoma Clinical Trial 2023: Gallium maltolate Highlights & Side Effects. Trial Name: NCT04319276 — Phase 1

Gallium maltolate (Metal Complex) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04319276 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity for this clinical trial?

"Affirmative. The clinical trial database suggests that this medical study, posted on March 11th 2022, is actively recruiting participants from one site with 24 patients needed in total. It was last updated September 20th of the same year."

Answered by AI

Is the study actively searching for participants at this time?

"Correct. Per the information on clinicaltrials.gov, this medical trial is currently enrolling patients - with its initial posting occurring on March 11th 2022 and having been recently updated on September 20th of that same year. 24 individuals are required across 1 site to complete the study's enrolment quota."

Answered by AI

What risks might patients face by taking the recommended dosage of Gallium maltolate?

"As this is an early-phase clinical trial, there is limited data about the efficacy and safety of Gallium maltolate (recommended phase 2 dose). Based on our assessment at Power, its safety was rated a 1."

Answered by AI

Have any prior studies explored the effectiveness of Gallium maltolate at a recommended phase 2 dose?

"Currently, there is one trial running which utilizes Gallium maltolate (recommended phase 2 dose). This study has yet to enter Phase 3 and is solely based in Milwaukee, Wisconsin."

Answered by AI