Trial · NCT02389244
A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas
NCT02389244, Phase 2, Completed, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas. Trials, record NCT02389244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02389244
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas
- NCT number
- NCT02389244
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 163 participants, actual
- Lead sponsor
- UNICANCER
- Conditions
- Ewing Sarcomas, Chondrosarcomas, Osteosarcomas, Chondroma, CIC-Rearranged Sarcoma
- Interventions
- Regorafenib, Placebo
- First posted
- 2015-03-17
- Last updated
- 2026-07-21
- Other registries' IDs
- eudract:2013-003910-42
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Non-progression rate | 8 weeks for cohorts A, B and E, 12 weeks for cohort C, 6 months for cohort D | Proportion of patients without disease progression at the defined timepoint after central radiological review (using RECIST 1.1) |
| Secondary | Progression Free Survival | expected average duration of 3 months | from the date of randomization until the date of radiological progression or death whatever the cause (if death occurs before progression) |
| Secondary | Objective response rate | 6 months | complete response (CR) or partial response (PR) according to RECIST 2009, version 1.1, for all cohorts, and CHOI criteria for chordoma |
| Secondary | Disease control rate at 6 months | 6 months | from the date of randomization until the date of death due to any cause |
| Secondary | Overall survival | 2 years | from the date of randomization until the date of death due to any cause |
| Secondary | Duration of response | expected average duration of 6 months | objective response of CR or PR, whichever is noted earlier, to first disease progression or death before progression |
| Secondary | Progression-free rate at 3 and 6 months | at 3 and 6 months | the proportion of patients without progression at 3 and 6 months post randomization |
| Secondary | Time to progression | from date of randomization until the date of first observation of progression (up to 6 months) | from date of randomization until the date of first observation of progression |
| Secondary | Growth Modulation Index defined as ratio of time to progressive disease (PD) under regorafenib to time to progression (TTP) under previous treatment | expected average duration of 3 months | ratio of time to PD under regorafenib to TTP under previous treatment |
| Secondary | Toxicity according to NCI-CTCAE V4-0 | expected average duration of 6 months | according to NCI-CTCAE V4-0 (National Cancer Institut Common Terminology Criteria for Adverse Events) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT02389244
GET https://conductscience.org/api/trials/v1/NCT02389244/registered