NCT03138629

Brief Summary

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to VAL-083 (dianhydrogalactitol) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

First QC Date

May 1, 2017

Last Update Submit

November 20, 2023

Conditions

Interventions

VAL-083 will be administered intravenously

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has relapsed/refractory disease and exhausted all standard treatments.

You may not qualify if:

  • Patient is eligible for a VAL-083 clinical trial.
  • Patient has previously received VAL-083 for the same disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 3, 2017

Last Updated

November 22, 2023

Record last verified: 2023-11