Trial · NCT05395741
Regorafenib in Patients With Refractory Primary Bone Tumors
NCT05395741, Phase 1, Phase 2, Completed, Institute of Mother and Child, Warsaw, Poland
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib in Patients With Refractory Primary Bone Tumors. Trials, record NCT05395741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05395741
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib in Patients With Refractory Primary Bone Tumors
- NCT number
- NCT05395741
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Institute of Mother and Child, Warsaw, Poland
- Conditions
- Osteosarcoma, Ewing Sarcoma of Bone
- Interventions
- Regorafenib
- First posted
- 2022-05-27
- Last updated
- 2026-10-07
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | EFS - (Event-Free Survival). | 1 year | To explore the efficacy in terms of EFS - (Event-Free Survival) |
| Primary | Determining the dose of the test substance in patients between 9 and 21 years of age, at which exposure to the drug will be similar to that recommended for adults. | 1 year | Safety will be assessed by the rate of participants presenting with Adverse Events stratified by grade, category, affected organ or system, as number of serious adverse events (SAEs) |
| Primary | Assessment of safety in terms of AEs | from date of randomization, until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months. | Safety will be assessed by the rate of participants presenting with Adverse Events stratified by grade, category, affected organ or system, as number of adverse events (AEs), including adverse events of special interest |
| Primary | Assessment of the safety of regorafenib | from date of randomization, until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months. | Safety will be assessed by analyzing recorded vital signs, laboratory test results, echocardiography, and ECG. |
| Secondary | PFS (Progression-Free Survival). | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | progression-free survival - will be measured from randomization to the detection of disease progression in imaging tests. |
| Secondary | OS (Overall Survival). | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | overall survival - will be measured from randomization to death due to cancer. |
| Secondary | ORR (Overall Response Rate). | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | the percentage of patients who achieved the response to treatment defined in the protocol. |
| Secondary | Time to achieving sufficient drug concentration in serum. | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | Concentration parameters will come directly from the concentration values measured in PK samples. |
| Secondary | Maximum serum concentration in steady state Cmaxs. | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | Concentration parameters will come directly from the concentration values measured in PK samples. |
| Secondary | Minimum serum concentration in steady state Cminss. | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | Concentration parameters will come directly from the concentration values measured in PK samples. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
Papers9
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/NCT05395741
GET https://conductscience.org/api/trials/v1/NCT05395741/registered