Methods of Identifying Effective Off-Guideline Treatments for Advanced Cancer Patients (CC N-of-1) (NCT07343024)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (5 items).
Location: Cancer Commons — Palo Alto, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Cancer Commons — Palo Alto, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.