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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03215511




Registration number
NCT03215511
Ethics application status
Date submitted
30/06/2017
Date registered
12/07/2017

Titles & IDs
Public title
A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer
Scientific title
A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers
Secondary ID [1] 0 0
LOXO-EXT-17005
Secondary ID [2] 0 0
20810
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors Harboring NTRK Fusion 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Selitrectinib (BAY2731954)

Experimental: Cancer participants <12 years - A Rolling-6 dose escalation design will be used. The starting dose for participants age \< 12 years will be 25% below the highest dose level cohort divided by 1.73 m\^2 cleared by the Safety Review Committee (SRC) for subjects age 12 years and older.

Experimental: Cancer participants =12 years - A 3+3 dose escalation design will be used to determine the maximum tolerated dose (MTD)/recommended dose for further study, enrolling 3 to 6 participants per cohort with a starting dose level of 100 mg twice daily (BID).


Treatment: Drugs: Selitrectinib (BAY2731954)
Selitrectinib is administered as capsules or liquid formulation.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum tolerated dose (MTD)
Timepoint [1] 0 0
Up to 42 days
Primary outcome [2] 0 0
Recommended dose
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Incidence of adverse events
Timepoint [1] 0 0
Up to 56 months
Secondary outcome [2] 0 0
Severity of adverse events
Timepoint [2] 0 0
Up to 56 months
Secondary outcome [3] 0 0
Duration of adverse events
Timepoint [3] 0 0
Up to 56 months
Secondary outcome [4] 0 0
Number of subjects with safety-relevant changes in clinical parameters or vital signs after drug administration
Timepoint [4] 0 0
Up to 56 months
Secondary outcome [5] 0 0
Severity of safety-relevant changes in clinical parameters or vital signs after drug administration
Timepoint [5] 0 0
Up to 56 months
Secondary outcome [6] 0 0
Overall response rate (ORR) in subjects with NTRK fusion cancer previously treated with TRK inhibitor determined by investigator
Timepoint [6] 0 0
Up to 56 months
Secondary outcome [7] 0 0
Overall response rate (ORR) in subjects with primary central nervous system (CNS) malignancies determined by investigator
Timepoint [7] 0 0
Up to 56 months
Secondary outcome [8] 0 0
Maximum concentration (Cmax) of BAY2731954 in plasma
Timepoint [8] 0 0
Predose, 0.25, 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 1, predose, 0.5, 1, 2, 4 post-dose on Day 8 of Cycle 1 (cycle length 28 days)
Secondary outcome [9] 0 0
Area under the concentration versus time curve of BAY2731954 in plasma (AUC (0-10), AUC(0-12) for BID dosing and AUC(0-24) for QD dosing)
Timepoint [9] 0 0
At defined time points for different cohort, up to 10 hours post-dose

Eligibility
Key inclusion criteria
* Advanced solid tumor for which, in the opinion of the investigator, no other standard therapy offers greater benefit.
* A solid tumor diagnosis in the setting of:

* a) a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor
* b) a documented NTRK fusion unresponsive to a prior TRK inhibitor
* c) a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
* NTRK gene fusions will be identified in a CLIA-certified (or equivalently-accredited diagnostic) laboratory. If such a report cannot be provided, other available certifications/accreditations are required and need to be documented. Patients with infantile fibrosarcoma (IFS) or congenital mesoblastic nephroma (CMN) may be enrolled based on an ETV6+ FISH test without identifying NTRK3.
* Performance Status: Eastern Cooperative Oncology Group (ECOG) score = 2 in adults or Karnofsky Performance Status (KPS) Score=50% (age = 16 years) or Lansky Performance Score (LPS) = 40% (age < 16 years).
* Life expectancy of at least 3 months.
* Adequate hematologic, hepatic and renal function.
* Patients with stable central nervous system (CNS) primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms have been stable for 7 days prior to the first dose of selitrectinib.
* Ability to receive study drug orally or by enteral administration
Minimum age
1 Month
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, repotrectinib [TPX-0005]), taletrectinib [DS-6501b/AB-106]). Exception is in case patient presented intolerance to the second generation TRK inhibitor agent and the duration of exposure was less than 28 days. No previous treatment with selitrectinib is allowed.
* Concurrent treatment with a strong CYP3A4 inhibitor or inducer, consumption of grapefruit juice or Seville oranges, or drugs associated with QT prolongation.
* Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of selitrectinib, or prolongation of QT interval corrected for heart rate (QTc interval) >480 milliseconds within past 6 months
* Major surgery within 7 days of enrollment
* Uncontrolled systemic bacterial, fungal or viral infection.
* Pregnancy or lactation.
* Known hypersensitivity to selitrectinib or Ora-Sweet® SF and OraPlus® for patients receiving liquid formulation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/01/2023
Sample size
Target
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Children's Hospital Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Dakota
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Belgium
State/province [14] 0 0
Edegem
Country [15] 0 0
Denmark
State/province [15] 0 0
Copenhagen
Country [16] 0 0
France
State/province [16] 0 0
PARIS cedex 5
Country [17] 0 0
France
State/province [17] 0 0
Villejuif Cedex
Country [18] 0 0
Germany
State/province [18] 0 0
Baden-Württemberg
Country [19] 0 0
Ireland
State/province [19] 0 0
Dublin
Country [20] 0 0
Italy
State/province [20] 0 0
Lombardia
Country [21] 0 0
Singapore
State/province [21] 0 0
Singapore
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03215511