← Back to Search

Kinase Inhibitor

Larotrectinib for TRK Fusion Cancers and Acute Leukemia

Q: Are there other ongoing investigations involving Larotrectinib Sulfate?

Larotrectinib Sulfate was first studied in 2004 at Bronson Methodist Hospital. As of now, there are 69 completed trials and 74 active clinical trials. A large proportion of these studies take place in Tampa, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>.

Q: How many people are included in the experimental group for this research?

The correct. According to the clinicaltrials.gov website, this clinical trial is still recruiting patients. The listing was first created on September 18th, 2019 and updated as recently as October 19th, 2022. They are hoping to enroll 70 individuals across 81 different locations.

Q: Are patients still being accepted for this trial?

The listed clinical trial on clinicaltrials.gov is currently looking for patients. The study was first made public on September 18th, 2019 and the most recent update occurred on October 19th, 2020.

Q: What are the main benefits of Larotrectinib Sulfate?

Larotrectinib Sulfate is indicated for use in patients with NTRK3 gene fusions, as well as those with solid tumors, NTRK2 gene fusions, and no known acquired resistance mutations.

Q: Can you tell me how many different hospitals are participating in this trial?

There are many sites where this study is taking place, but the three main locations for recruitment are Saint Joseph's Hospital/Children's Hospital-Tampa in Tampa, Nicklaus Children's Hospital in Miami, and Children's Healthcare of Atlanta - Egleston in Atlanta.

Q: What have been the reported dangers of Larotrectinib Sulfate?

Larotrectinib Sulfate is still in the early stages of testing, so it only received a 2 in terms of safety.

Phase 2

Waitlist Available

Led By Theodore W Laetsch

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Patients must be =< 30 years of age at the time of study entry

COHORT C: Patients must have a histologic diagnosis of relapsed or refractory acute leukemia with an NTRK1, NTRK2, or NTRK3 fusion identified in a CLIA/CAP certified laboratory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial studies the side effects and effectiveness of larotrectinib in treating patients with solid tumors or acute leukemia that have a specific genetic mutation (TRK fusion). Larotrectinib may stop the growth of cancer cells by blocking the TRK enzymes needed for cell growth.

Who is the study for?

This trial is for patients under 30 with untreated TRK fusion solid tumors or relapsed acute leukemia. They must have no prior cancer treatment except surgery, meet blood and organ function criteria, not be pregnant or breastfeeding, able to swallow capsules or have gastric access, and not on certain medications.Check my eligibility

What is being tested?

The study tests Larotrectinib's effectiveness in blocking TRK enzymes to stop cancer cell growth in those with specific genetic markers (NTRK1, NTRK2, NTRK3 fusions). It includes young patients who haven't tried other treatments and whose disease has measurable indicators of progress.See study design

What are the potential side effects?

While the trial primarily investigates efficacy, potential side effects may include issues related to enzyme inhibition that could affect cell growth regulation. Specific side effects are not listed but would generally relate to the drug's action on cellular pathways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 30 years old or younger.

Select...

My leukemia has come back or didn't respond to treatment, and tests show NTRK fusion.

Select...

My nervous system disorder is mild.

Select...

My organs are functioning well.

Select...

I have not had any cancer treatment except for surgery.

Select...

I have never taken TRK inhibitor medications.

Select...

I can do most activities but may need help.

Select...

I have infantile fibrosarcoma with an NTRK fusion confirmed by a certified lab.

Select...

I have recovered from side effects of my previous cancer treatments.

Select...

My tumor, not a high-grade glioma or infantile fibrosarcoma, has an NTRK fusion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Objective response rate (ORR) of children with infantile fibrosarcoma (IFS) treated with neoadjuvant larotrectinib prior to local control

Secondary outcome measures

DoR of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control

Duration of response (DoR) of children with IFS treated with neoadjuvant larotrectinib prior to local control

EFS of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (larotrectinib)Experimental Treatment1 Intervention

Patients receive larotrectinib PO or by NG or G-tube BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity, or complete surgical resection of tumor.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,597 Total Patients Enrolled

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,630 Total Patients Enrolled

Theodore W LaetschPrincipal InvestigatorChildren's Oncology Group

1 Previous Clinical Trials

18 Total Patients Enrolled

Media Library

Larotrectinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03834961 — Phase 2

Infantile Fibrosarcoma Clinical Trial 2023: Larotrectinib Highlights & Side Effects. Trial Name: NCT03834961 — Phase 2

Larotrectinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03834961 — Phase 2

Frequently Asked Questions

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

Are there other ongoing investigations involving Larotrectinib Sulfate?

"Larotrectinib Sulfate was first studied in 2004 at Bronson Methodist Hospital. As of now, there are 69 completed trials and 74 active clinical trials. A large proportion of these studies take place in Tampa, Florida."

Answered by AI

How many people are included in the experimental group for this research?

"The correct. According to the clinicaltrials.gov website, this clinical trial is still recruiting patients. The listing was first created on September 18th, 2019 and updated as recently as October 19th, 2022. They are hoping to enroll 70 individuals across 81 different locations."

Answered by AI

Are patients still being accepted for this trial?

"The listed clinical trial on clinicaltrials.gov is currently looking for patients. The study was first made public on September 18th, 2019 and the most recent update occurred on October 19th, 2020."

Answered by AI

What are the main benefits of Larotrectinib Sulfate?

"Larotrectinib Sulfate is indicated for use in patients with NTRK3 gene fusions, as well as those with solid tumors, NTRK2 gene fusions, and no known acquired resistance mutations."

Answered by AI

Can you tell me how many different hospitals are participating in this trial?

"There are many sites where this study is taking place, but the three main locations for recruitment are Saint Joseph's Hospital/Children's Hospital-Tampa in Tampa, Nicklaus Children's Hospital in Miami, and Children's Healthcare of Atlanta - Egleston in Atlanta."

Answered by AI