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FoundationOne Testing for Rare Cancers (TRACK Trial)

N/A
Recruiting
Led By James Cleary, M.D., Ph.D.
Research Sponsored by TargetCancer Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether patients with rare tumors can benefit from treatment based on their NGS results.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
As this trial focuses on matching therapies to genetic profiles rather than specific drugs, side effects will vary depending on individualized treatment plans derived from the genomic profiling results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.
Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.
Secondary study objectives
Comparison of Tumor Biomarker Profiling to Treatment Outcome.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

TargetCancer FoundationLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Foundation MedicineIndustry Sponsor
32 Previous Clinical Trials
15,784 Total Patients Enrolled
James Cleary, M.D., Ph.D.Principal InvestigatorDana-Farber Cancer Institute
Roman Groisberg, M.D.Principal InvestigatorRutgers Cancer Institute of New Jersey
Shumei Kato, M.D.Principal InvestigatorUniversity of California, San Diego
Vivek Subbiah, M.D.Principal InvestigatorSCRI Development Innovations, LLC
Razelle Kurzrock, M.D.Principal InvestigatorMedical College of Wisconsin
2 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Other remaining rare cancers (solid tumors & lymphomas) Clinical Trial Eligibility Overview. Trial Name: NCT04504604 — N/A
Rare Cancers Research Study Groups: Other remaining rare cancers (solid tumors & lymphomas), Cancer of Unknown Primary (CUP), Cholangiocarcinoma
Rare Cancers Clinical Trial 2023: Other remaining rare cancers (solid tumors & lymphomas) Highlights & Side Effects. Trial Name: NCT04504604 — N/A
Other remaining rare cancers (solid tumors & lymphomas) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04504604 — N/A
~54 spots leftby Sep 2025
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