FoundationOne Testing for Rare Cancers

(TRACK Trial)

Overseen By Mary Oster

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TargetCancer Foundation

Disqualifiers: Uncontrolled illness, Active malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 years

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if rare cancer patients can benefit from personalized treatment based on their genetic makeup. It uses FoundationOne CDx (a comprehensive genomic profiling test) and FoundationOne Liquid CDx to match patients with therapies tailored to their tumor's specific genetic profile. The trial includes individuals with very uncommon cancers, such as cholangiocarcinoma (a type of bile duct cancer), cancers of unknown origin, and other rare solid tumors or lymphomas. It suits those diagnosed with a rare cancer who are willing to provide tissue and blood samples for genetic testing. As an unphased trial, it offers a unique opportunity for patients to access cutting-edge personalized treatments tailored to their genetic profile.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that FoundationOne CDx and FoundationOne Liquid CDx are safe for use in patients with rare cancers?

Research has shown that both FoundationOne CDx and FoundationOne Liquid CDx have received FDA approval, indicating they have passed safety checks for their intended uses. FoundationOne CDx is used for solid tumors, while FoundationOne Liquid CDx analyzes genes from a blood sample.

Studies indicate that these tests are safe because they involve analyzing samples rather than administering drugs. No reports have linked negative effects directly to the tests. They work by examining the genetic makeup of tumors, aiding doctors in selecting the best treatment.

In summary, the FDA has approved both FoundationOne CDx and Liquid CDx for other uses, suggesting their safety for testing. This approval instills confidence in their safety for use in clinical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FoundationOne CDx and FoundationOne Liquid CDx because they offer a personalized approach to diagnosing and treating rare cancers. Unlike traditional methods that might rely on broad, one-size-fits-all treatments, these tests analyze the genetic makeup of a patient's tumor, allowing doctors to tailor therapies specifically to each individual's cancer. This precision can lead to more effective treatments with potentially fewer side effects. Additionally, the liquid biopsy option provides a less invasive way to obtain crucial genetic information, which is particularly beneficial for patients unable to undergo traditional tissue biopsies.

What evidence suggests that this trial's treatments could be effective for rare cancers?

Research has shown that the FoundationOne CDx and FoundationOne Liquid CDx tests can identify the best treatments for patients with rare cancers. In this trial, participants with various rare cancers, including Cancer of Unknown Primary (CUP) and Cholangiocarcinoma, will undergo assessment using these tests. The FDA-approved FoundationOne CDx test examines 324 genes related to cancer in solid tumors, aiding doctors in selecting treatments based on the specific genetics of a patient's tumor. Similarly, the FoundationOne Liquid CDx test, a simple blood test, analyzes important cancer genes and also holds FDA approval. These tests aim to find effective treatments by examining the unique genetic details of each cancer, potentially improving patient outcomes. ^{1 2 3 5 6}

Who Is on the Research Team?

Shumei Kato

Principal Investigator

University of California, San Diego

Vivek Subbiah, M.D.

Principal Investigator

SCRI Development Innovations, LLC

Razelle Kurzrock, M.D.

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

Adults with rare solid tumors or lymphoma, who can provide consent and have an ECOG performance status of 0-2. They must be willing to share medical information, undergo blood draws, and provide tissue samples for genomic profiling. Excluded are those under 18, pregnant or breastfeeding women, individuals with uncontrolled illnesses that could affect study compliance, or active cancer requiring treatment within the past year.

Inclusion Criteria

For archival tissue to be used for comprehensive genomic profiling for the present study, that specimen must have been harvested within 18 months of the baseline visit (i.e. date of consent) of the present study

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Stated willingness to comply with all study related blood draws and assessments for the duration of the study

Exclusion Criteria

Participants who are unable to provide informed consent

Participants who are 17 years of age or younger

Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genomic Profiling

Participants undergo comprehensive genomic profiling of their tumor and plasma circulating cell-free DNA

4 weeks

1 visit (in-person or remote)

Treatment

Participants receive molecularly targeted matched treatment based on genomic profiling results

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• FoundationOne CDx
• FoundationOne Liquid CDx

Trial Overview The TRACK Study is testing whether patients with rare cancers benefit from treatments based on their tumor's genetic profile using FoundationOne CDx and Liquid CDx tests. It's a practical trial where participants' previous biopsy samples are analyzed to guide therapy choices.

How Is the Trial Designed?

Group I: Other remaining rare cancers (solid tumors & lymphomas) Active Control 1 Intervention

Eligible patients that meet the definition of rare cancers (incidence of less than 6 per 100,000 in the United States).

Group II: Cancer of Unknown Primary (CUP) Active Control 1 Intervention

Eligible patients with cancer of unknown primary site (CUP).

Group III: Cholangiocarcinoma Active Control 1 Intervention

Eligible patients that present with Cholangiocarcinoma.

Who Is Running the Clinical Trial?

TargetCancer Foundation

Lead Sponsor

Trials

2

Recruited

410+

Foundation Medicine

Industry Sponsor

Trials

37

Recruited

17,600+

Published Research Related to This Trial

In a study of 43 Japanese patients with advanced solid tumors, the FoundationOne CDx test successfully identified actionable gene mutations in 96% of cases, indicating its potential clinical utility in guiding treatment decisions.

Despite the high detection rate of mutations, only 15% of patients received treatments corresponding to their identified mutations, primarily due to disease progression and reduced performance status, highlighting challenges in translating genomic findings into clinical action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical Utility of Comprehensive Genome Profiling Using FoundationOne CDx in Japanese Population(PROFILE-F Study)]. Kumaki, Y., Takahashi, K., Mitsumura, T., et al.[2020]

The FoundationOne®Liquid CDx assay, a cfDNA-based genomic profiling tool, has been validated through over 7,500 tests, demonstrating high accuracy in detecting genomic alterations across more than 30 cancer types, with a positive agreement of 96.3% compared to other methods.

This assay shows a very low false positive rate of 0.013% and high reproducibility (99.59%), making it a reliable option for identifying patients who may benefit from precision therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and analytical validation of FoundationOne Liquid CDx, a novel 324-Gene cfDNA-based comprehensive genomic profiling assay for cancers of solid tumor origin. Woodhouse, R., Li, M., Hughes, J., et al.[2020]

FoundationOne®CDx (F1CDx) is an FDA-approved diagnostic test that uses next-generation sequencing to analyze 324 cancer genes, helping identify patients who may benefit from 28 specific cancer therapies.

The extensive analytical and clinical validation of F1CDx, based on over 30,000 test results, demonstrates its high sensitivity and reliability, ensuring accurate matching of patients with solid tumors to appropriate targeted therapies or immunotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and analytical validation of FoundationOne®CDx, a comprehensive genomic profiling assay for solid tumors. Milbury, CA., Creeden, J., Yip, WK., et al.[2022]

In a study of 109,695 patients with solid tumors, FoundationOneCDx identified clinically significant genomic alterations in about 51.2% of tumor profiles, which can guide treatment decisions for various cancer therapies.

The test revealed that 89.2% of solid tumor profiles contained genomic results that could potentially inform the selection of immunotherapy and targeted therapy clinical trials, highlighting its utility in personalized cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights of Clinical Significance From 109 695 Solid Tumor Tissue-Based Comprehensive Genomic Profiles. Heilmann, AM., Riess, JW., McLaughlin-Drubin, M., et al.[2023]

In a study of 130 Japanese patients with advanced solid tumors, clinical sequencing identified actionable gene alterations in 87.7% of cases, suggesting a high potential for personalized treatment options.

Despite the promising results, only 22.3% of patients received treatment based on these genetic findings, indicating that while clinical sequencing is useful, there are still challenges in implementing these insights into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of comprehensive genomic profiling in Japan: Result of PROFILE-F study. Aoyagi, Y., Kano, Y., Tohyama, K., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8926248/

Clinical and analytical validation of FoundationOne®CDx, a ... FoundationOne®CDx (F1CDx) is a United States (US) Food and Drug Administration (FDA)-approved companion diagnostic test to identify patients ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170019S054B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) FoundationOne CDx (F1CDx) is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput ...

3. foundationmedicine.com foundationmedicine.com/test/foundationone-cdx

FoundationOne CDx | Foundation ... FoundationOne CDx is the first FDA-approved tissue-based broad companion diagnostic (CDx) that is clinically and analytically validated for all solid tumors.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0264138

Clinical and analytical validation of FoundationOne®CDx, a ... F1CDx utilizes next-generation sequencing (NGS)-based comprehensive genomic profiling (CGP) technology to examine 324 cancer genes in solid tumors.

5. info.foundationmedicine.com info.foundationmedicine.com/hubfs/FMI%20Labels/FoundationOne_CDx_Label_Technical_Info.pdf

Page 1 of 110 FoundationOne®CDx Technical Information ... Clinical efficacy results in the CDx-positive population for solid tumor patients with ... trials which enrolled patients with solid tumors with. NTRK1/2/3 ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170019S014C.pdf

FoundationOne®CDx Technical Information The likelihood of a patient receiving this result is ~3.29% within solid tumors. • Patients with solid tumors may also receive an MSI status reported as “Cannot ...