Methods of Identifying Effective Off-Guideline Treatments for Advanced Cancer Patients (CC N-of-1)

Summary

Many FDA-approved drugs are not available to patients with a particular cancer because there has been no successful clinical trial conducted for that drug against that cancer. In the absence of such a successful clinical trial, the drug is not included in the National Comprehensive Cancer Network (NCCN) guidelines list of approved drugs for that cancer. The absence of a drug in the NCCN Guidelines for a particular cancer is usually not an indication that the drug has been shown to be ineffective for patients with that cancer. Rather, it is an indication that there is insufficient clinical trial evidence to include it. A drug that is FDA-approved for one or more cancers but is not in the NCCN Guidelines for a particular cancer is called an "off-guideline" drug for that cancer. This study is being done to measure and compare the reliability of multiple different treatment selection tests to predict a participant's response to an off- guideline cancer therapy. The results can guide oncologists to effective off-guideline drugs that would otherwise not be available to their advanced cancer patients. As this is an observational study, all the data gathered and analyzed will be generated in the normal practice of medicine, not by the study.

Eligibility

Inclusion Criteria:

* Participant must have a valid genomic or functional test or willing to undergo a new test
* Analysis of the participant's test must produce a set of Promising Off-guideline Drug(s)
* Oncologist must be willing to administer one or more Promising Off-guideline Drug(s)
* The study team must have an approved method of paying for the administered Off-Guideline Drug(s). Health insurance and self-pay are the two most common sources of payment
* Participant must sign the Informed Consent

Exclusion criteria:

* No set of Promising Off-guideline Drug(s)
* Oncologist not willing to administer one or more Promising Off-guideline Drug(s)
* No approved method of paying for the administered off-guideline Drug(s)
* No signed Informed Consent

Conditions2

Locations1 site

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