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Topoisomerase I inhibitor and Alkylating agent

Repotrectinib + Chemotherapy for Cancer

Phase 1 & 2
Recruiting
Led By Emily Slotkin, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy prior to study enrollment
Patients with primary CNS tumors must meet specific neurological stability and performance score criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will test the safety of repotrectinib in combination with chemo in children & young adults with advanced solid tumors. The goal is to find the highest dose that causes few side effects. They'll also evaluate whether it's an effective treatment & study how the body processes the drug.

Who is the study for?
This trial is for children and young adults with advanced or metastatic solid tumors who have not responded to standard therapy. They must have a certain level of physical ability, no severe infections, and meet specific blood count and organ function criteria. Pregnant individuals or those on strong CYP3A4 inhibitors are excluded.Check my eligibility
What is being tested?
Researchers are testing the safety of repotrectinib combined with chemotherapy drugs irinotecan and temozolomide. The goal is to find the highest dose with minimal side effects, then see if it's effective against these types of cancers in youths.See study design
What are the potential side effects?
Possible side effects include reactions related to drug infusion, digestive issues that might affect how the drug works, nerve pain (neuropathy), blood disorders from bone marrow involvement, liver problems like jaundice or hepatitis, heart issues such as abnormal rhythms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have recovered from side effects of my previous cancer treatments.
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My brain tumor does not affect my daily activities much.
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My cancer can be measured or seen on tests.
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My condition did not improve after standard treatment.
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My blood counts and organ functions meet the required levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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) (phase I)
incidence of Dose Limiting Toxicity (DLTs) (phase I)

Trial Design

1Treatment groups
Experimental Treatment
Group I: RepotrectinibExperimental Treatment2 Interventions
Phase 1: Part A : TPX-0005 (Repotrectinib) will be given orally (without regard to food) once daily for 14 days, then increased to twice daily for remainder of cycles and concurrently administered with chemotherapy backbone described below. For patients less than 12 years old or less than 50kg, adult equivalent dosing (AED) will be used. Approximately 4-24 pediatric subjects will be enrolled into 2-4 dose levels (pending if DL-1 or DL-1b are utilized), with maximum of 6 subjects per dose level according to the 'rolling 6' design. Starting dose of TPX-0005 (Repotrectinib) will begin at dose level (DL) 1. Part B (combination therapy; patients less than 12 years old or ≤ 50kg): For 6 additional patients, a safety run-in will be conducted with TPX-0005 (Repotrectinib) and chemotherapy.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,939 Previous Clinical Trials
588,925 Total Patients Enrolled
Emily Slotkin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
508 Total Patients Enrolled
Tara O'Donohue, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Irinotecan and Temozolomide (Topoisomerase I inhibitor and Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT05004116 — Phase 1 & 2
Cancer Research Study Groups: Repotrectinib
Cancer Clinical Trial 2023: Irinotecan and Temozolomide Highlights & Side Effects. Trial Name: NCT05004116 — Phase 1 & 2
Irinotecan and Temozolomide (Topoisomerase I inhibitor and Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05004116 — Phase 1 & 2

Frequently Asked Questions

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

Who might this trial be most beneficial for?

"This clinical trial is for children aged 1-25 who have cancer that has progressed. They are looking to recruit 50 participants."

Answered by AI

For what purpose is Repotrectinib most commonly prescribed?

"Repotrectinib is most often used to treat melanoma, but it can also be given to patients with other conditions like soft tissue sarcoma (sts), primary central nervous system lymphoma (pcnsl), and malignant neoplasms."

Answered by AI

Could you explain the age requirement for participation in this research?

"This clinical trial is only for individuals aged 1 to 25. Out of the 381 trials available for people under 18 and 2790 trials available for those over 65, this one is most applicable to you."

Answered by AI

How many guinea pigs are needed for this scientific experiment?

"That is accurate. The clinical trial in question, as indicated by information on clinicaltrials.gov, is still looking for participants. This particular trial was posted on 8/9/2021 and edited more recently on 8/22/20222. They are recruiting 50 individuals from 1 site total."

Answered by AI

Are investigators still enrolling volunteers for this research project?

"Yes, the website clinicaltrials.gov has information indicating that this medical trial is recruiting patients right now. The original posting was on August 9th, 2021 with the most recent update occurring on August 22nd, 2022. They are looking to enroll 50 individuals at a single location."

Answered by AI

What are the previous findings of research projects involving Repotrectinib?

"As of now, 463 clinical trials concerning Repotrectinib are ongoing with 77 being in Phase 3. While the majority of studies related to Repotrectinib originate from Boston, Massachusetts, there are 12930 locations conducting these medical trials."

Answered by AI
~30 spots leftby Aug 2028