RECRUITING

A Study of Repotrectinib in Combination with Chemotherapy in Children and Young Adults with Solid Tumor Cancer

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Conditions

Advanced CancerMetastatic Solid TumorRepotrectinib21-156

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will test the safety of the study drug, repotrectinib, in combination with chemotherapy (irinotecan and temozolomide) in children and young adults who have advanced or metastatic solid tumors. We researchers will try to find the highest dose of the study drug that causes few or mild side effects in study participants. When the researchers find this dose, we will evaluate it in a different group of participants to find out whether repotrectinib in combination with chemotherapy is an effective treatment for children and young adults who have advanced/metastatic solid tumors. Another purpose of the study is to look at the way the body absorbs, distributes, and gets rid of repotrectinib.

Official Title

Phase 1/2 Study of TPX-0005 (Repotrectinib) in Combination with Chemotherapy in Pediatric and Young Adult Subjects with Advanced or Metastatic Solid Tumors and Primary Central Nervous System Tumors

Quick Facts

Study Start:2021-08-09
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05004116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Phase 1- patients with known bone marrow disease
  2. * Concurrent participation in another therapeutic clinical trial
  3. * Neuroblastoma patients with only bone marrow disease evaluable only by bone marrow aspiration
  4. * Major surgery within 14 days (2 weeks) prior to C1D1. Central venous access (Broviac, MediPort) placement does not meet criteria for major surgery.
  5. * Pregnancy or lactation
  6. * Known active systemic infections requiring ongoing treatment (bacterial, fungal, viral including human immunodeficiency virus positivity). Skin or other superficial infections requiring topical treatment only are not an exclusion.
  7. * Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
  8. * Peripheral neuropathy CTCAE grade ≥ 3.
  9. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study, or could compromise protocol objectives in the opinion of the Investigator and/or Turning Point Therapeutics.
  10. * Current use or anticipated need for drugs that are known to be strong CYP3A4 inhibitors or inducers
  11. * Disease progression while on treatment with irinotecan/temozolomide.
  12. * Gilbert Syndrome or Crigler-Najjar
  13. * Prolonged QTc: 450m/s for male patients and 470ms for female patients.

Contacts and Locations

Study Contact

Emily Slotkin, MD
CONTACT
1-833-675-5437
slotkine@mskcc.org
Fiorella Iglesias Cardenas, MD,MS
CONTACT
1-833-675-5437

Principal Investigator

Emily Slotkin, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Emily Slotkin, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-09
Study Completion Date2028-08

Study Record Updates

Study Start Date2021-08-09
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Repotrectinib
  • 21-156

Additional Relevant MeSH Terms

  • Advanced Cancer
  • Metastatic Solid Tumor