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RecruitingLast updated: 15 August 2023

TAILOR: This trial is evaluating individually tailored treatment plans in people with advanced cancers who are accessing targeted therapy cancer drugs through compassionate accessSafety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Clinical summary

Summary

When seriously ill patients run out of standard treatment options, they will often consider non-standard treatment options (such as treatments that are currently unapproved by the regulatory agency for the given indication). In general, an access program enables patient access to a non-reimbursed therapeutic agent, outside of a clinical trial setting. Compassionate access is typically for therapeutics that are not yet approved or TGA registered, and are still considered investigational. Compassionate access is an established process with increasing demands. This study is designed to provide a framework for which patients treated with compassionate access therapeutics can register, so that some of the limitations of ad hoc compassionate access programs can be overcome. A study committee will prospectively assess each individual patient's detailed treatment approach in an objective and time-efficient manner. If approved, the patient may be eligible to register into the treatment phase of the study. All participants will have an individualised treatment plan. Possible treatments include targeted therapies.

Conditions

This trial is treating patients with locally advanced, incurable or metastatic cancer.

Cancer

Advanced Cancers Advanced

Age

People2+

Phase

Not applicable

Trial Acronym

TAILOR

More information

Trial Identifiers

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Commercial Sponsor

Peter MacCallum Cancer Centre

Scientific Title

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Eligibility

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.