Solid Tumor, AdultLAROTRACKINGNCT04814667
A Retro-/Prospective, Non-interventional, Cohort Study in Adult Patients With Locally Advanced or Metastatic Tumors With a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion, Treated With Larotrectinib
An observational study of Solid Tumor, Adult and Locally Advanced Solid Tumor, run by Centre Leon Berard at 4 sites in France.
Trial summary
Larotrectinib, a selective TRK inhibitor has showed marked and durable antitumor activity in patients with NTRK gene-fusion-positive tumors regardless of the tumor type, gene partner and patient's age. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Solid Tumor, Adult, Locally Advanced Solid Tumor, Metastatic Cancer
- How many people
- 26 participants
- Where
- 4 sitesFrance
- Study dates
- 23 Feb 2021to 15 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with locally advanced or metastatic tumors with a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, treated with Larotrectinib
Who may be able to join
- Adult male or female patients
- Histological confirmed diagnosis of advanced/metastatic solid tumor type.
- Patients previously, currently or to be treated with Larotrectinib within the ATU/post-ATU period. Patient must be > 25 years-old at time of larotrectinib start.
- Patients not opposed to collection of personal clinical data
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Amiens
Amiens
Centre Georges Francois Leclerc
Dijon
Centre Leon Berard
Lyon
Chi Elbeuf Louviers
Saint-Aubin-lès-Elbeuf
About this study
Official title: LAROTRACKING - A Retro-/Prospective, Non-interventional, Cohort Study in Adult Patients With Locally Advanced or Metastatic Tumors With a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion, Treated With Larotrectinib
Larotrectinib, a selective TRK inhibitor has showed marked and durable antitumor activity in patients with NTRK gene-fusion-positive tumors regardless of the tumor type, gene partner and patient's age. Because of this and the lack of alternative therapy in this rare but severe disease, the French National Agency for Medicines and Health Products Safety (ANSM) granted in April 2019, a "cohort" Temporary Authorization for Use (ATU) in the indication:"Larotrectinib is indicated as monotherapy for the treatment of adult and paediatric patients from one month, with locally advanced or metastatic solid tumours with a Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, refractory to standard treatments or in the absence of appropriate therapeutic alternative." Despite the potential benefit of identifying these fusions, the clinicopathologic features of NTRK fusion-positive tumors which are treated with Larotrectinib, are not well characterized. This study will provide information about the diagnosis and management of patients with locally advanced or metastatic NTRK fusion cancer treated with Larotrectinib under real-world treatment conditions in France, and describes the dosing patterns, safety and effectiveness of this agent.
Read the detailed description
Tropomyosin receptor kinases (TRK) are a family of tyrosine kinases that bind neurotrophins, a family of growth factors important to the formation and function of the nervous system. In cancer, the neurotrophic tyrosine kinase receptor (NTRK)1, NTRK2 and NTRK3 genes, which encode for the TRKA, TRKB and TRKC proteins, respectively, are subject to gene-arrangements that lead to kinase domain expression and constitutive downstream pathway activation. In preclinical models, NTRK gene fusions have transformative oncogenic potential, and they appear to be widely distributed across histologically diverse adult and pediatric cancers. Hence, these genetic abnormalities, observed in both children and adults, have recently emerged as targets for cancer therapy.
Larotrectinib, a selective TRK inhibitor has showed marked and durable antitumor activity in patients with NTRK gene-fusion-positive tumors regardless of the tumor type, gene partner and patient's age.
Because of this and the lack of alternative therapy in this rare but severe disease, the French National Agency for Medicines and Health Products Safety (ANSM) granted in April 2019, a "cohort" Temporary Authorization for Use (ATU) in the indication:
"Larotrectinib is indicated as monotherapy for the treatment of adult and paediatric patients from one month, with locally advanced or metastatic solid tumours with a Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, refractory to standard treatments or in the absence of appropriate therapeutic alternative." Despite the potential benefit of identifying these fusions, the clinicopathologic features of NTRK fusion-positive tumors which are treated with Larotrectinib, are not well characterized.
This study will provide information about the diagnosis and management of patients with locally advanced or metastatic NTRK fusion cancer treated with Larotrectinib under real-world treatment conditions in France, and describes the dosing patterns, safety and effectiveness of this agent.
- Keywords
- NTRK gene fusion, Larotrectinib, Neurotrophic Tyrosine Receptor Kinase gene fusion, NTRK rearrangements
- Medical subject headings
- Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical activity of larotrectinib
Best objective response rate (BORR) (Complete Response or Partial Response according to RECIST V1.1 classification i.e assessed by investigators)
Measured: From the date of the first larotrectinib dose until the date of objectively documented progression or date of subsequent anti-cancer therapy, whichever came first, assessed up to 60 months.
Clinical activity of larotrectinib
Duration of response (DOR) (Best overall response of Complete Response or Partial Response according to RECIST V1.1 classification i.e assessed by investigators)
Measured: From the start of Complete Response or Partial Response (whichever response came first) until the date of observed disease progression or death due to any cause, whichever came first, assessed up to 60 months.
Clinical activity of larotrectinib
Time to response (TTR)
Measured: From the start of larotrectinib treatment until the first evidence of Objective Response according to RECIST V1.1 classification i.e assessed by investigators), assessed up to 60 months. Time to response will be calculated for responders only.
Clinical activity of larotrectinib
Progression-free survival (PFS)
Measured: From the start of Larotrectinib treatment until the date of first observed disease progression (radiological or clinical, whichever came first) or death due to any cause, whichever came first, assessed up to 60 months
Clinical activity of larotrectinib
Overall survival (OS)
Measured: From the start of larotrectinib treatment until the date of death, due to any reason, assessed up to 60 months. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up.
Secondary outcomes (6)
Clinicopathological features of patients with locally advanced or metastatic NTRK fusion cancer for whom a decision to treat with larotrectinib was made before enrolment.
Demographics data, significant or relevant medical history, cancer disease overview
Measured: Through study completion, an average of 60 months.
Diagnosis strategy for detection of NTRK fusions in the investigational centers
Description of the diagnosis tests used for NTRK fusions
Measured: Through study completion, an average of 60 months.
Treatment(s) received prior to and after larotrectinib.
Doses, duration, best tumor response and reasons for discontinuation
Measured: From the first dose of larotrectinib until the day of permanent discontinuation of larotrectinib (including death), assessed up to 60 months .
Patterns of larotrectinib treatment
Dosing paramaters
Measured: From the start of larotrectinib treatment until the day of permanent discontinuation of larotrectinib (including death), assessed up to 60 months
Safety of larotrectinib
Adverse events : Nature, frequency and severity of Adverse Events (AEs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) graded using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Measured: Through study completion, an average of 60 months.
Molecular characteristics of NTRK rearrangements
Gene name, type of alteration
Measured: Through study completion, an average of 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start23 Feb 2021
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Armelle DUFRESNE, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814667
- Sponsor's protocol ID
- LAROTRACKING
- Acronym
- LAROTRACKING
- Status last verified
- Jul 2023
- First submitted
- 19 Mar 2021
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAROTRACKING - A Retro-/Prospective, Non-interventional, Cohort Study in Adult Patients With Locally Advanced or Metastatic Tumors With a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion, Treated With Larotrectinib
- ClinicalTrials.gov ID
- NCT04814667
- Acronym / sponsor ID
- LAROTRACKING / LAROTRACKING
- Keywords
- NTRK gene fusion, Larotrectinib, Neurotrophic Tyrosine Receptor Kinase gene fusion, NTRK rearrangements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Larotrectinib, a selective TRK inhibitor has showed marked and durable antitumor activity in patients with NTRK gene-fusion-positive tumors regardless of the tumor type, gene partner and patient's age. Because of this and the lack of alternative therapy in this rare but severe disease, the French National Agency for Medicines and Health Products Safety (ANSM) granted in April 2019, a "cohort" Temporary Authorization for Use (ATU) in the indication:"Larotrectinib is indicated as monotherapy for the treatment of adult and paediatric patients from one month, with locally advanced or metastatic solid tumours with a Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, refractory to standard treatments or in the absence of appropriate therapeutic alternative." Despite the potential benefit of identifying these fusions, the clinicopathologic features of NTRK fusion-positive tumors which are treated with Larotrectinib, are not well characterized. This study will provide information about the diagnosis and management of patients with locally advanced or metastatic NTRK fusion cancer treated with Larotrectinib under real-world treatment conditions in France, and describes the dosing patterns, safety and effectiveness of this agent.
Detailed description
Tropomyosin receptor kinases (TRK) are a family of tyrosine kinases that bind neurotrophins, a family of growth factors important to the formation and function of the nervous system. In cancer, the neurotrophic tyrosine kinase receptor (NTRK)1, NTRK2 and NTRK3 genes, which encode for the TRKA, TRKB and TRKC proteins, respectively, are subject to gene-arrangements that lead to kinase domain expression and constitutive downstream pathway activation. In preclinical models, NTRK gene fusions have transformative oncogenic potential, and they appear to be widely distributed across histologically diverse adult and pediatric cancers. Hence, these genetic abnormalities, observed in both children and adults, have recently emerged as targets for cancer therapy.
Larotrectinib, a selective TRK inhibitor has showed marked and durable antitumor activity in patients with NTRK gene-fusion-positive tumors regardless of the tumor type, gene partner and patient's age.
Because of this and the lack of alternative therapy in this rare but severe disease, the French National Agency for Medicines and Health Products Safety (ANSM) granted in April 2019, a "cohort" Temporary Authorization for Use (ATU) in the indication:
"Larotrectinib is indicated as monotherapy for the treatment of adult and paediatric patients from one month, with locally advanced or metastatic solid tumours with a Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, refractory to standard treatments or in the absence of appropriate therapeutic alternative." Despite the potential benefit of identifying these fusions, the clinicopathologic features of NTRK fusion-positive tumors which are treated with Larotrectinib, are not well characterized.
This study will provide information about the diagnosis and management of patients with locally advanced or metastatic NTRK fusion cancer treated with Larotrectinib under real-world treatment conditions in France, and describes the dosing patterns, safety and effectiveness of this agent.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with locally advanced or metastatic tumors with a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, treated with Larotrectinib
Key inclusion criteria (4 listed)
- Adult male or female patients
- Histological confirmed diagnosis of advanced/metastatic solid tumor type.
- Patients previously, currently or to be treated with Larotrectinib within the ATU/post-ATU period. Patient must be > 25 years-old at time of larotrectinib start.
- Patients not opposed to collection of personal clinical data
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical activity of larotrectinib
Time frame: From the date of the first larotrectinib dose until the date of objectively documented progression or date of subsequent anti-cancer therapy, whichever came first, assessed up to 60 months.
Best objective response rate (BORR) (Complete Response or Partial Response according to RECIST V1.1 classification i.e assessed by investigators)
Clinical activity of larotrectinib
Time frame: From the start of Complete Response or Partial Response (whichever response came first) until the date of observed disease progression or death due to any cause, whichever came first, assessed up to 60 months.
Duration of response (DOR) (Best overall response of Complete Response or Partial Response according to RECIST V1.1 classification i.e assessed by investigators)
Clinical activity of larotrectinib
Time frame: From the start of larotrectinib treatment until the first evidence of Objective Response according to RECIST V1.1 classification i.e assessed by investigators), assessed up to 60 months. Time to response will be calculated for responders only.
Time to response (TTR)
Clinical activity of larotrectinib
Time frame: From the start of Larotrectinib treatment until the date of first observed disease progression (radiological or clinical, whichever came first) or death due to any cause, whichever came first, assessed up to 60 months
Progression-free survival (PFS)
Clinical activity of larotrectinib
Time frame: From the start of larotrectinib treatment until the date of death, due to any reason, assessed up to 60 months. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up.
Overall survival (OS)
6 secondary outcomes
Clinicopathological features of patients with locally advanced or metastatic NTRK fusion cancer for whom a decision to treat with larotrectinib was made before enrolment.
Time frame: Through study completion, an average of 60 months.
Diagnosis strategy for detection of NTRK fusions in the investigational centers
Time frame: Through study completion, an average of 60 months.
Treatment(s) received prior to and after larotrectinib.
Time frame: From the first dose of larotrectinib until the day of permanent discontinuation of larotrectinib (including death), assessed up to 60 months .
Patterns of larotrectinib treatment
Time frame: From the start of larotrectinib treatment until the day of permanent discontinuation of larotrectinib (including death), assessed up to 60 months
Safety of larotrectinib
Time frame: Through study completion, an average of 60 months.
Molecular characteristics of NTRK rearrangements
Time frame: Through study completion, an average of 60 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armelle DUFRESNE principal investigator
Centre Leon Berard
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, Adult and Locally Advanced Solid Tumor, run by Centre Leon Berard at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical activity of larotrectinib (time frame: From the date of the first larotrectinib dose until the date of objectively documented progression or date of subsequent anti-cancer therapy, whichever came first, assessed up to 60 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.