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Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma

NCT01478178 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-08-29

No results posted yet for this 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.

Conditions

Interventions

DRUG

VAL-083 (Dianhydrogalactitol)

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.

Sponsors & Collaborators

  • Kintara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Howard A Burris, M.D. · Sarah Cannon Research Institute; Nashville, Tennessee 37203, USA

  • Manish Patel, M.D. · Florida Cancer Specialists, Sarasota, Florida 34232, USA

  • Nicholas Butowski, M.D. · University of California, San Francisco, 94143, USA

  • Sani Kizilbash, M.D. · Mayo Clinic, Rochester, Minnesota 55905, USA

  • Gerald Falchook, M.D. · Sarah Cannon Research Institute; Denver, Colorado 80218 USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-12-31
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01478178 on ClinicalTrials.gov