check_circleStudy Completed

Cancer

Bayer Identifier:

20703

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY2757556, no drug Larotrectinib related - OS

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - 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).
  • - 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
15971
Trial Dates
March 2019 - September 2019
Phase
N/A
Could I Receive a placebo
N/A
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, United States

Primary Outcome

  • Overall survival - Index date 1 as the date of comprehensive genomic profiling (CGP) report
    date_rangeTime Frame:
    Data from January 2011 to July 2018

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
N/A

Additional Information

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