Recruiting

Observational Study

Sponsor:

Cancer Commons

Code:

NCT07343024

Conditions

Advanced Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Advanced Cancer

Study ID

NCT07343024

Start date

Mar 30, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

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 ]

Central Contacts and Locations

Locations

Cancer Commons

Recruiting

Palo Alto, California, United States, 94306

Contacts

Clifford Reid, PhD

877-971-1200StudyTeam_CCCS001@cancercommons.org

Principal Investigator:

Clifford Reid, PhD

More Information

Sponsor

Cancer Commons

Last update posted

Oct 8, 2026

Last verified

Sep, 2026

Keywords

  • Off-Guideline
  • Advanced Cancer Treatments
  • Functional Precision Medicine
  • Drug Sensitivity Tests
  • Treatment Selection Tests
  • Genomic Tests
  • Off-label drugs
  • Predictive Accuracy of tests

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Cancer Commons on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.