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Small Molecule Inhibitor

Selitrectinib (BAY2731954) for Solid Tumors

Q: Has a similar investigation previously been conducted?

To date, only one ongoing trial for Selitrectinib (BAY2731954) exists across 34 cities and 15 countries. The first such study was run by Bayer in 2017 and had 81 participants; it completed Phase 1 approval with success. There have been two further trials since then which have concluded.

Q: Are there other investigations with Selitrectinib (BAY2731954) in progress?

Selitrectinib (BAY2731954) was first explored in National <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center during the year 2017. To date, 2 trials have been finished and 1 is actively recruiting--primarily at medical centres within Toronto, Ontario.

Q: Are there still opportunities for individuals to participate in this research study?

This study is no longer enrolling participants. It was initially published on July 3rd 2017, and the latest update was released on November 2nd 2022. Those seeking alternative clinical trials can find three studies recruiting patients with solid tumors harboring NTRK fusion, as well as one trial for Selitrectinib (BAY2731954).

Q: Has the FDA validated Selitrectinib (BAY2731954) as a therapeutic agent?

Selitrectinib (BAY2731954) has been assigned a safety rating of 1, as we are still in the early stages of understanding its efficacy and potential hazards.

Q: What is the current capacity to enroll participants in this experiment?

This study is not currently taking applications, however it was initially posted on July 3rd 2017 and last edited November 2nd 2022. If you are searching for other trials to apply for, there are three studies with solid tumors harboring ntrk fusion recruiting as well as one trial involving Selitrectinib (BAY2731954) actively seeking participants.

Q: How many physical centers are responsible for executing this trial?

This research project is being conducted in 30 locations across North America; namely, Sunnybrook Health Sciences Centre in Toronto, Ontario, University Hospitals Cleveland Medical Center in Cleveland, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a> and CHU Sainte-Justine in Montreal Quebec.

Phase 1

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 56 months

Awards & highlights

Study Summary

This trial is testing a new drug, selitrectinib, for safety in children and adults with cancer who have a change in a particular gene. The drug may work by interfering with the effect of the NTRK genes on cancer growth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 56 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 56 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD)

Recommended dose

Secondary outcome measures

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)

Duration of adverse events

Incidence of adverse events

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cancer participants ≥12 yearsExperimental Treatment1 Intervention

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).

Group II: Cancer participants <12 yearsExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selitrectinib (BAY2731954)

2020

Completed Phase 1

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,240 Previous Clinical Trials

25,332,668 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a similar investigation previously been conducted?

"To date, only one ongoing trial for Selitrectinib (BAY2731954) exists across 34 cities and 15 countries. The first such study was run by Bayer in 2017 and had 81 participants; it completed Phase 1 approval with success. There have been two further trials since then which have concluded."

Answered by AI

Are there other investigations with Selitrectinib (BAY2731954) in progress?

"Selitrectinib (BAY2731954) was first explored in National Cancer Center during the year 2017. To date, 2 trials have been finished and 1 is actively recruiting--primarily at medical centres within Toronto, Ontario."

Answered by AI

Are there still opportunities for individuals to participate in this research study?

"This study is no longer enrolling participants. It was initially published on July 3rd 2017, and the latest update was released on November 2nd 2022. Those seeking alternative clinical trials can find three studies recruiting patients with solid tumors harboring NTRK fusion, as well as one trial for Selitrectinib (BAY2731954)."

Answered by AI

Has the FDA validated Selitrectinib (BAY2731954) as a therapeutic agent?

"Selitrectinib (BAY2731954) has been assigned a safety rating of 1, as we are still in the early stages of understanding its efficacy and potential hazards."

Answered by AI

What is the current capacity to enroll participants in this experiment?

"This study is not currently taking applications, however it was initially posted on July 3rd 2017 and last edited November 2nd 2022. If you are searching for other trials to apply for, there are three studies with solid tumors harboring ntrk fusion recruiting as well as one trial involving Selitrectinib (BAY2731954) actively seeking participants."

Answered by AI

How many physical centers are responsible for executing this trial?

"This research project is being conducted in 30 locations across North America; namely, Sunnybrook Health Sciences Centre in Toronto, Ontario, University Hospitals Cleveland Medical Center in Cleveland, Ohio and CHU Sainte-Justine in Montreal Quebec."

Answered by AI

Recent research and studies

Annals of OncologyJournal

Tumour Response to TRK Inhibition in a Patient with Pancreatic Adenocarcinoma Harbouring an NTRK Gene Fusion

O’Reilly, E.M., and J.F. Hechtman. 2019. “Tumour Response to TRK Inhibition in a Patient with Pancreatic Adenocarcinoma Harbouring an NTRK Gene Fusion”. Annals of Oncology. Elsevier BV. doi:10.1093/annonc/mdz385.

Annals of OncologyJournal

Tumour Response to TRK Inhibition in a Patient with Pancreatic Adenocarcinoma Harbouring an NTRK Gene Fusion

Annals of OncologyJournal

Tumour Response to TRK Inhibition in a Patient with Pancreatic Adenocarcinoma Harbouring an NTRK Gene Fusion

clinicaltrials.govStudy

A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer

2017. "A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03215511.