Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT04504604

Recruiting

TRACK: TCF-001 TRACK (Target Rare Cancer Knowledge) Study

Interventional

Phase not listed

TargetCancer Foundation

Sponsor: TargetCancer Foundation

Last Updated: August 9, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

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Treatment Category

Diagnostic Test

Required Mutations

None

Trial Started

October 1, 2020

Last Updated by Sponsor

August 9, 2024

Estimated Completion

September 1, 2025

Contact Study

Name:Mary Oster

Email:track@targetcancerfoundation.org

Phone:617-299-0389

Eligibility

Inclusion Criteria

* Provision of signed and dated informed consent form.

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

* Individuals who are 18 years old or older at the time of consent.

* Patients with a rare (fewer than 6 cases per 100,000 per year) solid tumor or lymphoma with evaluable disease at baseline. The complete list of included cancers are included in the study protocol; diseases not listed in the study protocol may be enrolled with the approval of the Principal Investigator.

* May or may not have had qualifying (by Foundation Medicine) comprehensive genomic profiling before the present study. For those who have had qualifying comprehensive genomic profiling performed prior to the present study, the archival specimen tested must have been harvested within 18 months of the baseline visit (i.e. date of consent) of the present study.

* Willingness to provide existing archived and/or newly collected tissue resulting from standard of care procedures and blood samples for genomic profiling. If the submitted sample is determined to be insufficient for testing, the patient will be considered to be a screen failure.

* 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.

* Willingness to provide clinical and medical information to the study team as required.

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

* Ability to read, write and communicate in English.

* Ability to review and sign a web-based informed consent form, or review and sign an informed consent form in treating physician office.

* Resides within the United States.

Exclusion Criteria

* Participants who are unable to provide informed consent.

* Participants who are 17 years of age or younger.

* Participants who are unable to comply with the study procedures.

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

* Concurrent active malignancy requiring treatment within 1 year of enrollment, at the discretion of treating physician.

* Pregnancy or breastfeeding.

* Any unlisted criteria at the discretion of the treating physician.

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Design Details

AllocationNon-Randomized

Intervention ModelFactorial Assignment

MaskingNone (Open Label)

Number to Enroll400

Arms & Interventions

Arms

Interventions

Type: Active Comparator

Description: Eligible patients that present with Cholangiocarcinoma.

Interventions:

FoundationOne CDx and FoundationOne Liquid CDx

Outcome Measures

Primary Outcome Measures

Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.2 years

The primary feasibility endpoint is the percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB. Point estimates and confidence interval estimations will be calculated for percent of participants on matched treatments.

Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.2 years

The primary efficacy endpoint is the progression-free survival (PFS) among participants who received the molecularly targeted matched treatment. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including progression-free survival (PFS). Cox regression analysis will be applied to model PFS by putative covariates such as performance status, type of tumor, prior lines of treatment, and whether matched treatments are received.

Secondary Outcome Measures

Comparison of Tumor Biomarker Profiling to Treatment Outcome.2 years

Tumor molecular profiles will be correlated to treatment outcome, assessed by measures including the response rate, the rate of stable disease (SD)>6 months/partial response (PR)/complete response (CR), progression-free survival (PFS), PFS ratio (comparison of the PFS used after molecular profiling to PFS on prior treatment), time to treatment failure, and overall survival. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including overall survival (OS).

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Trial Sites

This study has 1 trial site

TargetCancer Foundation

Cambridge, Massachusetts, US

Name:Mary Oster

Email:track@targetcancerfoundation.org

Phone:617-299-0389

Recruiting

Cambridge, Massachusetts, 02139 US

TargetCancer Foundation

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