Trial · NCT02085148
A Phase I Dose Finding Study in Children With Solid Tumors Recurrent or Refractory to Standard Therapy
NCT02085148, Phase 1, Completed, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I Dose Finding Study in Children With Solid Tumors Recurrent or Refractory to Standard Therapy. Trials, record NCT02085148. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02085148
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I Dose Finding Study in Children With Solid Tumors Recurrent or Refractory to Standard Therapy
- NCT number
- NCT02085148
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 62 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Pediatric Oncology
- Interventions
- Regorafenib (BAY73-4506), Vincristine (Cellcristin®), Irinotecan (Irinotecan Cell pharm®)
- First posted
- 2014-03-12
- Last updated
- 2024-04-22
- Other registries' IDs
- eudract:2013-003579-36
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Maximum Tolerated Dose | approximately after 21 months | MTD is defined as the dose level at which none or 1 of 6 participants experiences dose-limiting toxicity (DLT), when at least 2 of 3-6 participants experience a DLT at the next highest dose |
| Primary | Safety: Recommended Phase II Dose | approximately after 21 months | In order to establish a RP2D, the MTD cohort will be expanded to have at least 12 evaluable subjects to confirm the RP2D. It is expected that at least 15 subjects evaluable for DLTs will be necessary to establish the RP2D of the combination" |
| Primary | Number of participants with Adverse Events | Dose escalation phase:approximately after 21 months; Expansion Phase: approximately after 21 months | Individual listings of adverse events will be provided. The incidence of treatment-emergent adverse events and drug-related adverse events, respectively, will be summarized by worst NCI-CTCAE v 4.0 grade and by dose level |
| Primary | AUC(0-24)md based on nominal dosing | Dose escalation phase:Cycle 1 Day 1, Day 15 and Day 21 | Dose escalation phase has been completed |
| Secondary | Overall survival | Dose escalation phase: approximately 21 months; Expansion phase: approximately 21 months | |
| Secondary | Time to progression | Dose escalation phase: approximately 21 months; Expansion phase: approximately 21 months | |
| Secondary | Tumor response: tumor assessment by RECIST v. 1.1 | Dose escalation phase: approximately 21 months; Expansion phase: approximately 21 months | |
| Secondary | Taste and texture questionnaire of the regorafenib formulations | Dose escalation phase: Cycle 1; Expansion phase:Concomitant: Cycle 1 Day 1;Sequential: Cycle 1 Day 8 | Expansion phase Dose escalation phase |
| Secondary | AUC(0-24)md based on nominal dosing | Expansion Phase:Cycle 1 Day1, Day 15 and Day 21 | Expansion phase |
| Secondary | Cmax(0-24)md based on individual dosing | Expansion Phase:Cycle 1 Day1, Day 15 and Day 21 | Expansion phase |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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.
Papers2
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/NCT02085148
GET https://conductscience.org/api/trials/v1/NCT02085148/registered