Trial · NCT02637687
A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children
NCT02637687, Phase 1, Phase 2, Active not recruiting, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children. Trials, record NCT02637687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02637687
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children
- NCT number
- NCT02637687
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 154 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Solid Tumors Harboring NTRK Fusion
- Interventions
- Larotrectinib (Vitrakvi, BAY2757556)
- First posted
- 2015-12-22
- Last updated
- 2025-06-22
- Other registries' IDs
- eudract:2016-003498-16
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of participants in an assigned dose cohort with treatment emergent adverse events (TEAEs) by grade assessed by NCI-CTCAE v 4.03 who experience a DLT | From Day 1 to Day 28 of Cycle 1 (1 Cycle=28 days) | DLT: Dose-limiting toxicity. NCI-CTCAE: National Cancer Institute-Common Terminology Criteria for Adverse Events. |
| Primary | Phase 1: Number of participants with TEAEs | From first dose of larotrectinib up to 93 months | |
| Primary | Phase 1: Severity of TEAEs | From first dose of larotrectinib up to 93 months | |
| Primary | Phase 2: Overall response rate (ORR) by IRRC | From first dose of Larotrectinib to disease progression or subsequent therapy or surgical intervention or death, up to 76 months | Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as determined by an independent radiology review committee (IRRC) based on Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, Response Assessment in Neuro Oncology (RANO) or International Neuroblastoma Response Criteria (INRC) as appropriate to tumor type who express NTRK gene fusions. |
| Secondary | Phase 1: Maximum concentration of larotrectinib in plasma (Cmax) | Cohort 1 and 2: Cycle 1 Day 1 (C1D1) at 1 and 4 hours post-dose and C2D1 at pre-dose, and at 1 and 4 hours post-dose; Cohort 3 and Dose Expansion Cohort: C1D1 at 1 and 4 hours post-dose and C4D1 at pre-dose, 1 and 4 hours post-dose | |
| Secondary | Phase 1: Area under the concentration versus time curve from time 0 to t (AUC0-t) of larotrectinib in plasma | Cohort 1 and 2: C1D1 at 1 and 4 hours post-dose and C2D1 at pre-dose, and at 1 and 4 hours post-dose; Cohort 3 and Dose Expansion Cohort: C1D1 at 1 and 4 hours post-dose and C4D1 at pre-dose, 1 and 4 hours post-dose | |
| Secondary | Phase 1: Oral clearance (CL/F) | Cohort 1 and 2: C1D1 at 1 and 4 hours post-dose and C2D1 at pre-dose, and at 1 and 4 hours post-dose; Cohort 3 and Dose Expansion Cohort: C1D1 at 1 and 4 hours post-dose and C4D1 at pre-dose, 1 and 4 hours post-dos | |
| Secondary | Phase 1: Cerebral spinal fluid/plasma ratio of larotrectinib | C1D1 in conjunction with the post-dose 1-hour PK sample | |
| Secondary | Phase 1: Maximum tolerated dose (MTD) | From C1D1 to C1D28 of treatment of each participant in each of the assigned dose cohort, up to 16 months | |
| Secondary | Phase 1: Recommended dose for Phase 2 | From the date a participants from assigned Cohort was administered the first dose to the date of the last dose for the last patient from the dose escalation phase, up to 16 months |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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.
Papers18
The papers the trial lists on ClinicalTrials.gov.
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/NCT02637687
GET https://conductscience.org/api/trials/v1/NCT02637687/registered?page=2