Children's Hospital Colorado | Pediatric Infectious Disease
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D).
Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.
Full description
Enrollment of subjects into Phase 1 will proceed concurrently by age as follows:
Phase 1:
Approximately 12 pediatric subjects with locally advanced or metastatic solid tumors, including a primary central nervous system (CNS) tumor, or anaplastic large cell lymphoma (ALCL), with disease progression or who are non-responsive or intolerant to available therapies and for which no standard or available curative therapy exists.
Phase 2:
Subjects will be enrolled in one of 3 cohorts as follows:
Cohort 1: approximately 10-20 subjects with solid tumors characterized by NTRK fusion, TRK tyrosine kinase inhibitor (TKI)-naïve, and centrally confirmed measurable disease at baseline.
Cohort 2: approximately 23 subjects with solid tumors characterized by NTRK fusion, TRK TKI-pretreated, and centrally confirmed measurable disease at baseline.
Cohort 3: approximately 20 subjects with solid tumors or ALCL characterized by other ALK/ROS1/NTRK alterations or NTRK fusions without centrally confirmed measurable disease not otherwise eligible for Cohort 1 or 2. As of the current protocol amendment, only patients with ROS1 alterations will be enrolled to this cohort.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Phase 2 Inclusion Criteria:
Cohort Specific Inclusion Criteria:
Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment.
Key Exclusion Criteria (Phase 1 and Phase 2):
Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.
Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.
Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity).
Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
Any of the following cardiac criteria:
Peripheral neuropathy of CTCAE ≥grade 2.
Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
Any potential allergies to repotrectinib and/or its excipients.
Primary purpose
Allocation
Interventional model
Masking
75 participants in 1 patient group
Loading...
Central trial contact
BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain the NCT# and Site #.
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal