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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Cancer Commons
Study ID
NCT07343024
Status
Recruiting
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Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

The predictive accuracy for each drug sensitivity testing (DST) used in the study [ Time Frame: Through study completion, an average of 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer CommonsPalo AltoCalifornia94306
Clifford Reid, PhD
[email protected]
877-971-1200
Clifford Reid, PhD (PRINCIPAL_INVESTIGATOR)
Prajit Pillai, PhD (PRINCIPAL_INVESTIGATOR)

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