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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.

Tracking Information
First Submitted Date May 1, 2017
First Posted Date May 3, 2017
Last Update Posted Date August 26, 2020
Descriptive Information
Brief Title Expanded Access to VAL-083
Official Title Expanded Access to VAL-083
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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients, Intermediate-size Population
Condition Cancer
Intervention Drug: VAL-083
VAL-083 will be administered intravenously
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Eligibility Criteria

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.
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Contact: John Langlands, Ph.D (604) 629-5989
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT03138629
Other Study ID Numbers DLM-17-002
Responsible Party Kintara Therapeutics, Inc.
Study Sponsor Kintara Therapeutics, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Kintara Therapeutics, Inc.
Verification Date August 2020