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Expanded Access to VAL-083

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03138629
Expanded Access Status : Available
First Posted : May 3, 2017
Last Update Posted : August 26, 2020
Information provided by (Responsible Party):
Kintara Therapeutics, Inc.

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.

Condition or disease Intervention/treatment
Cancer Drug: VAL-083

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Study Type : Expanded Access
Expanded Access Type : Individual Patients, Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to VAL-083

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: VAL-083
    VAL-083 will be administered intravenously

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03138629

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Contact: John Langlands, Ph.D (604) 629-5989

Sponsors and Collaborators
Kintara Therapeutics, Inc.
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Responsible Party: Kintara Therapeutics, Inc. Identifier: NCT03138629    
Other Study ID Numbers: DLM-17-002
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020