Trial · NCT02650401
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
NCT02650401, Phase 1, Phase 2, Active not recruiting, Hoffmann-La Roche
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options. Trials, record NCT02650401. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02650401
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
- NCT number
- NCT02650401
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 69 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Solid Tumors, CNS Tumors
- Interventions
- Entrectinib
- First posted
- 2016-01-08
- Last updated
- 2026-09-23
Source ClinicalTrials.gov
Registered outcomes69
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | Approximately 6 months | Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03) |
| Primary | Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules | Approximately 6 months | Assessed by NCI CTCAE v4.03 |
| Primary | Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules | Approximately 6 months | Assessed by NCI CTCAE v4.03 |
| Primary | Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube) | Approximately 6 months | Assessed by NCI CTCAE v4.03 |
| Primary | Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules | Approximately 6 months | Assessed by NCI CTCAE v4.03 |
| Primary | Cohort B: Objective Response Rate (ORR) | Approximately 6 months | Assessed by RANO per the BICR |
| Primary | Cohort D: ORR | Approximately 6 months | Assessed by RECIST v1.1 per the BICR |
| Secondary | Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03 | Approximately 24 months | AE, ECG and Labs assessed by NCI CTCAE v4.03 |
| Secondary | Maximum observed plasma drug concentration (Cmax) using F1 Formulation | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | Maximum observed plasma drug concentration (Cmax) using F06 Formulation given intact | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 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.
Papers3
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/NCT02650401
GET https://conductscience.org/api/trials/v1/NCT02650401/registered?page=2