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Alkylating agent

VAL-083 (Dianhydrogalactitol) for Brain Tumor

Phase 1 & 2
Waitlist Available
Led By Nicholas Butowski, M.D.
Research Sponsored by DelMar Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1: 0, 0.25, 0.5, 1, 2, 4, 6 hrs and immediately prior to cycle 1, day 2 dosing
Awards & highlights

Study Summary

The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.

Eligible Conditions
  • Brain Tumor
  • Glioblastoma
  • Brain Metastases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1: 0, 0.25, 0.5, 1, 2, 4, 6 hrs and immediately prior to cycle 1, day 2 dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1: 0, 0.25, 0.5, 1, 2, 4, 6 hrs and immediately prior to cycle 1, day 2 dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of maximum tolerated dose (MTD)
Secondary outcome measures
Characterization of Cycle 1 plasma pharmacokinetics
Evaluate tumor response in patients with recurrent malignant glioma

Trial Design

1Treatment groups
Experimental Treatment
Group I: VAL-083 (Dianhydrogalactitol)Experimental Treatment1 Intervention
VAL-083 given by intravenous infusion with a starting dose of 1.5 mg/m2 IV. Escalating doses to be administered in sequential dose cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dianhydrogalactitol
Not yet FDA approved

Find a Location

Who is running the clinical trial?

DelMar Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
2 Total Patients Enrolled
Nicholas Butowski, M.D.Principal InvestigatorUniversity of California, San Francisco, 94143, USA
1 Previous Clinical Trials
2 Total Patients Enrolled
Howard A Burris, M.D.Principal InvestigatorSarah Cannon Research Institute; Nashville, Tennessee 37203, USA
1 Previous Clinical Trials
14 Total Patients Enrolled
~4 spots leftby May 2025
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