FoundationOne Testing for Rare Cancers
(TRACK Trial)
Recruiting in Palo Alto (17 mi)
Overseen byRoman Groisberg, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: TargetCancer Foundation
Disqualifiers: Uncontrolled illness, Active malignancy, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results.
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.
How is FoundationOne Testing unique for rare cancers?
FoundationOne Testing is unique because it uses comprehensive genomic profiling to identify specific genetic changes in rare cancers, allowing for personalized treatment plans. This approach is different from standard treatments that may not consider individual genetic variations, potentially leading to more effective and targeted therapies.
12345Eligibility Criteria
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
+9 more
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
+4 more
Trial Timeline
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
Participant Groups
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.
3Treatment groups
Active Control
Group I: Other remaining rare cancers (solid tumors & lymphomas)Active Control1 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 Control1 Intervention
Eligible patients with cancer of unknown primary site (CUP).
Group III: CholangiocarcinomaActive Control1 Intervention
Eligible patients that present with Cholangiocarcinoma.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
TargetCancer FoundationCambridge, MA
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Who Is Running the Clinical Trial?
TargetCancer FoundationLead Sponsor
Foundation MedicineIndustry Sponsor
References
[Clinical Utility of Comprehensive Genome Profiling Using FoundationOne CDx in Japanese Population(PROFILE-F Study)]. [2020]FoundationOne CDx is a cancer genome profiling test that has already been approved by the FDA, but its clinical utility in Japanese patients is unknown. In this study, we examined the clinical utility of FoundationOne CDx.
Clinical and analytical validation of FoundationOne Liquid CDx, a novel 324-Gene cfDNA-based comprehensive genomic profiling assay for cancers of solid tumor origin. [2020]As availability of precision therapies expands, a well-validated circulating cell-free DNA (cfDNA)-based comprehensive genomic profiling assay has the potential to provide considerable value as a complement to tissue-based testing to ensure potentially life-extending therapies are administered to patients most likely to benefit. Additional data supporting the clinical validity of cfDNA-based testing is necessary to inform optimal use of these assays in the clinic. The FoundationOne®Liquid CDx assay is a pan-cancer cfDNA-based comprehensive genomic profiling assay that was recently approved by FDA. Validation studies included >7,500 tests and >30,000 unique variants across >300 genes and >30 cancer types. Clinical validity results across multiple tumor types are presented. Additionally, results demonstrated a 95% limit of detection of 0.40% variant allele fraction for select substitutions and insertions/deletions, 0.37% variant allele fraction for select rearrangements, 21.7% tumor fraction for copy number amplifications, and 30.4% TF for copy number losses. The limit of detection for microsatellite instability and blood tumor mutational burden were also determined. The false positive variant rate was 0.013% (approximately 1 in 8,000). Reproducibility of variant calling was 99.59%. In comparison with an orthogonal method, an overall positive percent agreement of 96.3% and negative percent agreement of >99.9% was observed. These study results demonstrate that FoundationOne Liquid CDx accurately and reproducibly detects the major types of genomic alterations in addition to complex biomarkers such as microsatellite instability, blood tumor mutational burden, and tumor fraction. Critically, clinical validity data is presented across multiple cancer types.
Clinical and analytical validation of FoundationOne®CDx, a comprehensive genomic profiling assay for solid tumors. [2022]FoundationOne®CDx (F1CDx) is a United States (US) Food and Drug Administration (FDA)-approved companion diagnostic test to identify patients who may benefit from treatment in accordance with the approved therapeutic product labeling for 28 drug therapies. F1CDx utilizes next-generation sequencing (NGS)-based comprehensive genomic profiling (CGP) technology to examine 324 cancer genes in solid tumors. F1CDx reports known and likely pathogenic short variants (SVs), copy number alterations (CNAs), and select rearrangements, as well as complex biomarkers including tumor mutational burden (TMB) and microsatellite instability (MSI), in addition to genomic loss of heterozygosity (gLOH) in ovarian cancer. CGP services can reduce the complexity of biomarker testing, enabling precision medicine to improve treatment decision-making and outcomes for cancer patients, but only if test results are reliable, accurate, and validated clinically and analytically to the highest standard available. The analyses presented herein demonstrate the extensive analytical and clinical validation supporting the F1CDx initial and subsequent FDA approvals to ensure high sensitivity, specificity, and reliability of the data reported. The analytical validation included several in-depth evaluations of F1CDx assay performance including limit of detection (LoD), limit of blank (LoB), precision, and orthogonal concordance for SVs (including base substitutions [SUBs] and insertions/deletions [INDELs]), CNAs (including amplifications and homozygous deletions), genomic rearrangements, and select complex biomarkers. The assay validation of >30,000 test results comprises a considerable and increasing body of evidence that supports the clinical utility of F1CDx to match patients with solid tumors to targeted therapies or immunotherapies based on their tumor's genomic alterations and biomarkers. F1CDx meets the clinical needs of providers and patients to receive guideline-based biomarker testing, helping them keep pace with a rapidly evolving field of medicine.
Insights of Clinical Significance From 109 695 Solid Tumor Tissue-Based Comprehensive Genomic Profiles. [2023]FoundationOneCDx is approved in the US and Japan as a companion diagnostic test to identify patients with cancer who may benefit from treatment with 30 drug therapies in the US and 23 in Japan. Tumor profiling with FoundationOneCDx also detects genomic findings with evidence of clinical significance that may inform clinical care decisions beyond companion diagnostic claims. This observational study reports the breadth and impact of clinical decision insights from FoundationOneCDx solid tumor profiles.
Clinical utility of comprehensive genomic profiling in Japan: Result of PROFILE-F study. [2022]Clinical sequencing has provided molecular and therapeutic insights into the field of clinical oncology. However, despite its significance, its clinical utility in Japanese patients remains unknown. Here, we examined the clinical utility of tissue-based clinical sequencing with FoundationOne® CDx and FoundationOne® Heme. Between August 2018 and August 2019, 130 Japanese pretreated patients with advanced solid tumors were tested with FoundationOne® CDx or FoundationOne® Heme.