Trial · NCT01900743
Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma
NCT01900743, Phase 2, Completed, Centre Oscar Lambret
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma. Trials, record NCT01900743. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01900743
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma
- NCT number
- NCT01900743
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 219 participants, actual
- Lead sponsor
- Centre Oscar Lambret
- Conditions
- Sarcoma
- Interventions
- Regorafenib, Placebo
- First posted
- 2013-07-16
- Last updated
- 2026-03-13
- Other registries' IDs
- eudract:2012-005743-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | Up to 2 years | Progression-Free Survival will be measured from the date of randomization until the date of radiological progression or death (if death occurs before progression). Progression-free rate at 3 and 6 months (PFR-3 and PFR-6), time to progression, response rate and duration of response, overall survival according to RECIST 1.1 criteria |
| Secondary | Growth modulation index | Up to 2 years | Growth modulation index in patients receiving regorafenib after randomization |
| Secondary | Toxicity according to NCI-CTC AE V4.0. | Baseline, every 4 weeks, up to the end of study | The monitoring of the toxicity of the regorafenib which can have a liver toxicity for exemple. |
| Secondary | Progression-free rate at 3 and 6 months (PFR-3 and PFR-6) | At month 3 and at month 6 | According to the RECIST 1.1 |
| Secondary | Time to progression | Up to 2 years | According to the RECIST 1.1 Every 4 weeks, Up to 2 years |
| Secondary | Overall survival | Up to 2 years | Time from the date of randomization to the date of death from any cause |
| Secondary | Response rate | Up to 2 years | the proportion of patients with the best overall tumor response of partial response (PR) or complete response (CR) according to RECIST 1.1 guidelines that is achieved during treatment or within 30 days after termination of study medication. |
| Secondary | Duration of response | Up to 2 years | the number of days from the date of first documented objective response of PR or CR, whichever is noted earlier, to first disease progression or death before progression. Patients without progression or death before progression at the time of analysis will be censored at the date of their last tumor assessment. |
| Other | Potential predictive factors for regorafenib response. | Up to 2 years | The monitoring of the factors which can induce a regorafenib response (Formalin fixed, paraffin embedded (FFPE) or fresh frozen tissue samples collected either from the primary tumor or from metastatic sites, or both will be analyzed) |
Source ClinicalTrials.gov
Outcomes0
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.
Papers5
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/NCT01900743
GET https://conductscience.org/api/trials/v1/NCT01900743/registered