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Small Molecule Inhibitor

Larotrectinib for Childhood Cancer (SCOUT Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from c1d1 to c1d28 of treatment of each participant in each of the assigned dose cohort, up to 16 months
Awards & highlights

SCOUT Trial Summary

This trial is testing the safety of a cancer drug called larotrectinib in children. The drug is designed to block the actions of genes in cancer cells. The trial will determine the dosage, how the drug is absorbed, and the response of different cancer types to the treatment.

Who is the study for?
This trial is for children and young adults up to age 21 with advanced or metastatic solid tumors, including CNS tumors that have not responded to other treatments. Eligible patients must have a specific gene change (NTRK fusion) in their cancer cells. Those with certain heart conditions, active infections, or recent major surgery are excluded.Check my eligibility
What is being tested?
The drug larotrectinib is being tested for safety and effectiveness in treating cancers with NTRK gene changes. The study has two parts: Phase 1 determines the safe dose for children and how they respond; Phase 2 examines the treatment's response duration across different cancer types.See study design
What are the potential side effects?
While specific side effects of larotrectinib in this trial aren't listed here, common ones may include fatigue, dizziness, nausea, liver enzyme elevation, constipation or diarrhea. Side effects can vary based on individual patient factors.

SCOUT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from c1d1 to c1d28 of treatment of each participant in each of the assigned dose cohort, up to 16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from c1d1 to c1d28 of treatment of each participant in each of the assigned dose cohort, up to 16 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
Phase 1: Number of participants in an assigned dose cohort with treatment emergent adverse events (TEAEs) by grade assessed by NCI-CTCAE v 4.03 who experience a DLT
Phase 1: Number of participants with TEAEs
Phase 1: Severity of TEAEs
+1 more
Secondary outcome measures
Phase 1: Area under the concentration versus time curve from time 0 to t (AUC0-t) of larotrectinib in plasma
Phase 1: Cerebral spinal fluid/plasma ratio of larotrectinib
Phase 1: Maximum concentration of larotrectinib in plasma (Cmax)
+19 more

SCOUT Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase 2: Primary CNS tumors_Cohort 3Experimental Treatment1 Intervention
Patients will receive larotrectinib dose on Day 1 (BID in accordance with the cohort assignment) at the recommended Phase 2 dose as determined in the Phase 1 portion of this study. Each cycle will consist of 28 days of continuous dosing. Individual patients will continue daily larotrectinib dosing until PD, unacceptable toxicity, or other reason for treatment discontinuation.
Group II: Phase 2: Patients with tumors bearing NTRK fusions (IFS)_Cohort 1Experimental Treatment1 Intervention
Patients will receive larotrectinib dose on Day 1 (BID in accordance with the cohort assignment) at the recommended Phase 2 dose as determined in the Phase 1 portion of this study. Each cycle will consist of 28 days of continuous dosing. Individual patients will continue daily larotrectinib dosing until PD, unacceptable toxicity, or other reason for treatment discontinuation. (arm closed)
Group III: Phase 2: Other extra-cranial solid tumors_Cohort 2Experimental Treatment1 Intervention
Patients will receive larotrectinib dose on Day 1 (BID in accordance with the cohort assignment) at the recommended Phase 2 dose as determined in the Phase 1 portion of this study. Each cycle will consist of 28 days of continuous dosing. Individual patients will continue daily larotrectinib dosing until PD, unacceptable toxicity, or other reason for treatment discontinuation. (arm closed)
Group IV: Phase 2: Bone health assessment_sub-cohortExperimental Treatment1 Intervention
Patients will receive larotrectinib dose on Day 1 (BID in accordance with the cohort assignment) at the recommended Phase 2 dose as determined in the Phase 1 portion of this study. Each cycle will consist of 28 days of continuous dosing. Individual patients will continue daily larotrectinib dosing until PD, unacceptable toxicity, or other reason for treatment discontinuation. Patients in this group will undergo bone health assessments in addition to all other efficacy and safety assessments.
Group V: Phase 1 dose expansionExperimental Treatment1 Intervention
Patients who are enrolled in the expansion cohort, following the formal dose escalation phase of the study. Distinct from the Phase 1 dose escalation cohort, the Phase 1 expansion cohort will enroll pediatric patients with advanced solid or primary CNS tumors with a documented NTRK gene fusion, or in the case of IFS, CMN or SBC with documented ETV6 rearrangement by FISH or RT-PCR or a documented NTRK fusion by NGS. This expansion cohort will follow the same schedule of assessments as the dose escalation cohorts. (arm closed)
Group VI: Phase 1 dose escalationExperimental Treatment1 Intervention
Patients will receive the different levels of dose on Day 1 (BID in accordance with the cohort assignment). Each cycle will consist of 28 days of continuous dosing. Individual patients will continue daily larotrectinib dosing until PD, unacceptable toxicity, or other reason for treatment discontinuation. (arm closed)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Larotrectinib (Vitrakvi, BAY2757556)
2014
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,229 Previous Clinical Trials
25,325,283 Total Patients Enrolled

Media Library

Larotrectinib (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02637687 — Phase 1 & 2

Frequently Asked Questions

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

How many participants are being monitored in this experiment?

"This clinical trial necessitates 155 volunteers who meet the outlined inclusion criteria. Those wishing to partake in this study can do so at British Columbia Childrens Hospital, located in Vancouver, or The Hospital for Sick Kids (SickKids) situated in Toronto."

Answered by AI

What medical conditions can be benefited from the application of Larotrectinib (Vitrakvi, BAY2757556)?

"Larotrectinib (Vitrakvi, BAY2757556) can be administered to patients with ntrk3 fusion positive and ntrk2 fusion positive tumors of a solid nature."

Answered by AI

Is this medical experiment actively seeking participants?

"Indeed, clinicaltrials.gov reveals that this medical study is open for recruitment and was initially published on December 16th 2015. Last updated November 14th 2022, the trial requires 155 participants to be recruited from 4 distinct sites."

Answered by AI

Are there any Canadian medical centers conducting this experimental trial?

"Clinics in British Columbia, Toronto and Philadelphia are actively enrolling patients for this medical trial. Additionally, there is another 4 sites spread across the country that have opened recruitment to participants."

Answered by AI

Has Larotrectinib (Vitrakvi, BAY2757556) been investigated in any additional clinical tests?

"Larotrectinib (Vitrakvi, BAY2757556) was initially trialled in 2015 at Alta Bates Summit Medical Center-Herrick Campus. There are 3 closed clinical trials and 8 active ones, many of which located in Vancouver, British Columbia."

Answered by AI
Recent research and studies
~4 spots leftby Jul 2024