Identifying off-guideline treatments that may work for advanced cancer
Methods of Identifying Effective Off-Guideline Treatments for Advanced Cancer Patients (CC N-of-1)
This project tests whether genomic and lab-based functional tests can help doctors choose FDA-approved off-guideline drugs that might work for people with advanced cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Commons Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT07343024 on ClinicalTrials.gov |
What this trial studies
This observational program collects participants' genomic and/or drug sensitivity test (DST) results and the Cancer Commons scientific team reviews those results alongside a targeted literature review to identify promising off-guideline drugs. The team produces a Scientific Report listing candidate treatments and shares it with the participant's oncologist, who decides whether to prescribe one or more off-guideline drugs. If an oncologist prescribes an off-guideline drug, the participant is enrolled and their subsequent treatment outcomes are recorded in the study database. The study compares multiple functional and genomic assays to estimate how accurately each predicts real-world treatment responses.
Who should consider this trial
Good fit: Ideal candidates are people with advanced cancer who have (or will obtain) genomic or functional test results, have an oncologist willing to prescribe identified off-guideline drugs, can arrange payment for those drugs, and can provide informed consent.
Not a fit: Patients without test results that yield promising off-guideline drugs, whose oncologists decline to prescribe them, who cannot secure payment for treatment, or who do not consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this work could help identify effective off-guideline treatment options for individual patients and speed clinical acceptance of functional testing for treatment selection.
How similar studies have performed: This approach is relatively novel and prior clinical evidence for functional assays guiding off-guideline drug selection is limited and not yet conclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Palo Alto, California
- Cancer Commons — Palo Alto, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.