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

ClinicalTrials.gov ID: NCT01478178

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Official title

Open-label, Single Arm, Safety and Tolerability Dose Escalation Study of VAL-083 in Patients With Recurrent Malignant Glioma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01478178
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Kintara Therapeutics, Inc.; Industry
Enrollment: 55 participants

Conditions and interventions

Conditions

Interventions

VAL-083 (Dianhydrogalactitol) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 70 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2011 (Type not available)
Primary completion: Dec 2015 (Actual)
Completion: Oct 2016 (Actual)
Last update posted: Aug 29, 2025

2011 – 2016

United States locations

U.S. sites: 5
U.S. states: 5
U.S. cities: 5

Facility	City	State	ZIP	Site status
University of California, San Francisco, Division of Neuro-Oncology	San Francisco	California	94143	—
Sarah Cannon Research Institute	Denver	Colorado	80218	—
Florida Cancer Specialists	Sarasota	Florida	34232	—
Mayo Clinic	Rochester	Minnesota	55905	—
Sarah Cannon Research Institute	Nashville	Tennessee	37203	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01478178, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 29, 2025 · Synced Nov 14, 2026