TCF-001 TRACK (Target Rare Cancer Knowledge) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTargetCancer Foundation
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
FoundationOne CDx and FoundationOne Liquid CDx
Diagnostic testEligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.
Treatment groups
400 Participants
are divided into 3 treatment groupsGroup A: CholangiocarcinomaActive comparator 1 intervention
Group B: Cancer of Unknown Primary (CUP)Active comparator 1 intervention
Group C: Other remaining rare cancers (solid tumors & lymphomas)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.
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.
Time frame
2 years2
Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.
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.
Time frame
2 yearsSecondary outcomes
1
Comparison of Tumor Biomarker Profiling to Treatment Outcome.
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).
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
TargetCancer Foundation
Lead sponsor
Foundation Medicine
Collaborator
Source ClinicalTrials.gov