Trial · NCT04094610
A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
NCT04094610, Phase 1, Phase 2, Recruiting, Turning Point Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations. Trials, record NCT04094610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04094610
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
- NCT number
- NCT04094610
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 75 participants, estimated
- Lead sponsor
- Turning Point Therapeutics, Inc.
- Conditions
- Locally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma, Primary CNS Tumors
- Interventions
- Oral repotrectinib (TPX-0005)
- First posted
- 2019-09-19
- Last updated
- 2026-09-25
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicities (DLTs) (Phase 1) | Within 28 days of the first repotrectinib dose | Define the dose limiting toxicities (DLTs) (Phase 1) |
| Primary | Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1) | Within 28 days of the last patient dosed in escalation | To determine the pediatric RP2D (Phase 1) |
| Primary | Overall Response Rate (ORR) (Phase 2) | Two to three years after first dose of repotrectinib | To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2) |
| Secondary | Overall Response Rate (ORR) (Phase 1) | Approximately three years | To determine the overall response rate (ORR) by Blinded Independent Central Review (BICR) (Phase 1) |
| Secondary | Clinical Benefit Rate (CBR) (Phase 1 and Phase 2) | Approximately three years | To determine the CBR of repotrectinib (TPX-0005) (Phase 1 and Phase 2) |
| Secondary | Time to response (TTR) (Phase 1 and Phase 2) | Approximately three years | To determine the TTR of reprotrectinib (TPX-005) (Phase 1 and Phase 2) |
| Secondary | Duration of response (DOR) (Phase 1 and Phase 2) | Approximately three years | To determine the DOR of repotrectinib (TPX-0005) (Phase 1 and Phase 2) |
| Secondary | Intracranial objective response rate (IC-ORR) (Phase 1 and Phase 2) | Approximately three years | To determine the IC-ORR of repotrectinib in subjects with measurable brain metastases (TPX-005) (Phase 1 and Phase 2) |
| Secondary | Central Nervous System Progression-Free Survival (CNS-PFS) (Phase 2) | Approximately three years | CNS-PFS in subjects with measurable brain metastases (Phase 2) |
| Secondary | Progression-free survival (PFS) (Phase 2) | Approximately three years | To determine the PFS (Phase 2) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34814185 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04094610
GET https://conductscience.org/api/trials/v1/NCT04094610/registered