Trial Condition(s):
Cancer
BAY2757556, no drug Larotrectinib related - OS (VOYAGER-1)
Bayer Identifier:
20703
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The primary objective of the study is to evaluate overall survival for cancer patients with NTRK gene fusion and cancer patients without any NTRK gene mutations including gene fusion or other rearrangements under current standard of care.
Secondary objectives comprise the frequency of NTRK fusions, other NTRK re-arrangements, patient characteristics, treatment patterns, overall survival for patients with other NTRK gene rearrangements and overall survival after the start of antineoplastic therapy.
Inclusion Criteria
- At least one documented clinical visit in the Flatiron network on or after January 1, 2011 and on or prior to July 31, 2018; - Underwent Comprehensive Genomic Profiling (CGP) testing by FMI on or prior to July 31, 2018 using a baitset that includes the coding exons of the NTRK gene family (NTRK1, NTRK2, NTRK3).
Exclusion Criteria
- Patients with death dates prior to 2012 were excluded * Eligible patients were classified into the following four cohorts based on CGP-reported NTRK gene fusion status and tumor type. * FMI began NGS test in August 2012. As a result, any patient with a death date before the start of 2012 would most likely be an error, so they are excluded to avoid any data issue.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
NTRK gene fusion-positive cancers: Patient profile and survival analysis in the real world setting using clinico-genomic data from Flatiron-FMI
Trial Type:
Observational
Intervention Type:
N/A
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
4
Primary Outcome
- Overall survival - Index date 1 as the date of comprehensive genomic profiling (CGP) reportTimeframe: Data from January 2011 to July 2018
Additional Information
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