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Trial · NCT00245102

Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma

NCT00245102, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-01-20

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma. Trials, record NCT00245102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00245102

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma
NCT number
NCT00245102
Status
Completed
Phases
Phase 2
Enrollment
147 participants, actual
Lead sponsor
National Cancer Institute (NCI)
Conditions
Adult Angiosarcoma, Adult Epithelioid Sarcoma, Adult Leiomyosarcoma, Adult Malignant Fibrous Histiocytoma, Adult Neurofibrosarcoma, Adult Synovial Sarcoma, Ovarian Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Uterine Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Uterine Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma, Uterine Leiomyosarcoma
Interventions
sorafenib tosylate
First posted
2005-10-27
Last updated
2014-05-23
Results first posted
2014-01-20

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOverall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTUp to 4 weeksA 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYOverall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTUp to 4 weeksparticipantsNUMBER

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTAngiosarcomaComplete Response1participants
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTMPNSTComplete Response0participants
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTLeiomyosarcomaComplete Response0participants
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTUndifferentiated Pleomorphic SarcomaComplete Response0participants
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTFibrosarcomaComplete Response0participants
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTOther HistologyComplete Response0participants
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTAngiosarcomaPartial Response4participants
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTMPNSTPartial Response0participants
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTLeiomyosarcomaPartial Response1participants
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECISTUndifferentiated Pleomorphic SarcomaPartial Response0participants

Participant flow18

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDAngiosarcoma44
Overall StudySTARTEDMPNST16
Overall StudySTARTEDLeiomyosarcoma46
Overall StudySTARTEDUndifferentiated Pleomorphic Sarcoma13
Overall StudySTARTEDFibrosarcoma5
Overall StudySTARTEDOther Histology23
Overall StudyCOMPLETEDAngiosarcoma37
Overall StudyCOMPLETEDMPNST12
Overall StudyCOMPLETEDLeiomyosarcoma39
Overall StudyCOMPLETEDUndifferentiated Pleomorphic Sarcoma10

Adverse events582

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAlanine aminotransferase increasedInvestigationsAngiosarcoma3443
otherAlanine aminotransferase increasedInvestigationsMPNST1161
otherAlanine aminotransferase increasedInvestigationsLeiomyosarcoma5465
otherAlanine aminotransferase increasedInvestigationsUndifferentiated Pleomorphic Sarcoma2132
otherAlanine aminotransferase increasedInvestigationsFibrosarcoma151
otherAlanine aminotransferase increasedInvestigationsOther Histology1231
otherAspartate aminotransferase increasedInvestigationsAngiosarcoma3443
otherAspartate aminotransferase increasedInvestigationsMPNST1161
otherAspartate aminotransferase increasedInvestigationsLeiomyosarcoma4464
otherAspartate aminotransferase increasedInvestigationsUndifferentiated Pleomorphic Sarcoma0130

Adverse event totals18

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityAngiosarcoma
Total, all-cause mortalityMPNST
Total, all-cause mortalityLeiomyosarcoma
Total, all-cause mortalityUndifferentiated Pleomorphic Sarcoma
Total, all-cause mortalityFibrosarcoma
Total, all-cause mortalityOther Histology
Total, other adverse eventsAngiosarcoma3644
Total, other adverse eventsMPNST1216
Total, other adverse eventsLeiomyosarcoma4046
Total, other adverse eventsUndifferentiated Pleomorphic Sarcoma1013

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P30CA008748Cancer Center Support GrantRudin, Charles M.SLOAN-KETTERING INST CAN RESEARCHNATIONAL CANCER INSTITUTE1985 to 2026

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT00245102

GET https://conductscience.org/api/trials/v1/NCT00245102/events?page=2