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New treatment option for Locally Advanced Solid Tumors
Official title A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
ClinicalTrials.gov ID: NCT04094610
What this study is testing
What is Oral repotrectinib (TPX-0005)?
Oral repotrectinib (TPX-0005) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for locally advanced solid tumors.
Also referred to as Oral repotrectinib (TPX-0005) capsules, Oral repotrectinib (TPX-0005) oral suspension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 25
You may be able to join if
- Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory...
- Phase 1: Age \<12 years; Phase 2: Age 12- 25 years
- Prior cytotoxic chemotherapy is allowed.
- Prior immunotherapy is allowed.
- Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria...
You likely can't join if
- (Phase 1 and Phase 2):
- people 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...
- 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...
- Any of the following cardiac criteria:
See the full eligibility criteria
- Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited...
- Phase 1: Age \<12 years; Phase 2: Age 12- 25 years
- Prior cytotoxic chemotherapy is allowed.
- Prior immunotherapy is allowed.
- Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal...
- All people must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.
- people with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment.
- people must have a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50.
- Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.
- Adequate hematologic, renal and hepatic function. Phase 2
- Cohort Specific
- Cohort 1: people with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve;
- Cohort 2: people with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated;
- Cohort 3: people with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease.
- people in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment. Key
- (Phase 1 and Phase 2):
- people 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:
- Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \> 480 msec obtained from three ECGs, using the screening clinic ECG...
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec)
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong...
- Peripheral neuropathy of CTCAE ≥grade 2.
- people being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
- Any potential allergies to repotrectinib and/or its excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Scarborough, Maine, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Randwick, New South Wales, Australia
- Westmead, New South Wales, Australia
- South Brisbane, Queensland, Australia
+ 33 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; Orlando, Florida, United States; Atlanta, Georgia, United States; Scarborough, Maine, United States; Boston, Massachusetts, United States and 47 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.