NCT07343024 · Cancer Commons
Methods of Identifying Effective Off-Guideline Treatments for Advanced Cancer Patients (CC N-of-1)
(CC N-of-1)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
The predictive accuracy for each drug sensitivity testing (DST) used in the study
Time frame: Through study completion, an average of 1 year
For each participant in the study who is treated with an off-guideline drug, the oncologist will provide the study with a binary assessment of "response" or "no response" from the participant, using the RECIST criteria or other criteria proposed by the treating oncologist. For each participant, we will compare the test prediction of "response" or "no response" to the oncologist assessment of "response" and "no response" to determine if the test prediction was correct or incorrect. For each test, we will compute the predictive accuracy of the test by dividing the number of correct predictions by dividing the number of correct predictions by the total number of predictions made by the test in the course of the study. For example, if a test made fifty (50) predictions and thirty five (35) of those predictions were correct, then the predictive accuracy of the test would be 35/50 = 70%.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Palo Alto, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations