Trial · NCT00400569
Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
NCT00400569, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2012-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma. Trials, record NCT00400569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00400569
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
- NCT number
- NCT00400569
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Liposarcoma, Leiomyosarcoma, Fibrosarcoma, Malignant Fibrous Histiocytoma
- Interventions
- Sunitinib Malate (SU011248)
- First posted
- 2006-11-17
- Last updated
- 2012-08-28
- Results first posted
- 2012-08-28
- Limitations and caveats
The trial was amended to exclude fibrosarcoma after only one patient was accrued while the other cohorts had completed 75% or more of their planned accrual. Only patients with liposarcoma, leiomyosarcoma, or MFH were enrolled after this amendment.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Overall Response (OR) | From On Treatment to Off Study - average of 6 months | Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST). |
| Secondary | Participants' Progression Free Survival (PFS) | From On Treatment to Off Study - average of 6 months | Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST). |
| Secondary | Participants' Overall Survival (OS) | From On Treatment to Off Study - average of 6 months | The median OS times (months) for liposarcoma, leiomyosarcoma and MFH. |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | 4 years, 7 months | Determine the number of participants who experience Serious Adverse events while on sunitinib malate study. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Overall Response (OR) | From On Treatment to Off Study - average of 6 months | All participants assessable for response | participants | NUMBER |
| SECONDARY | Participants' Progression Free Survival (PFS) | From On Treatment to Off Study - average of 6 months | All participants who completed the study | months | MEDIAN |
| SECONDARY | Participants' Overall Survival (OS) | From On Treatment to Off Study - average of 6 months | All participants who completed the study | months | MEDIAN |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | 4 years, 7 months | All Participants | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Overall Response (OR) | Experimental: Sunitinib Malate (SU011248) Treatment | 1 | participants | ||
| Participants' Progression Free Survival (PFS) | Liposarcoma Cohort Only | 3.9 | 95% Confidence Interval 2.8 to 4.4 | months | |
| Participants' Progression Free Survival (PFS) | Leiomyosarcoma Cohort Only | 4.2 | 95% Confidence Interval 2.0 to 8.3 | months | |
| Participants' Progression Free Survival (PFS) | Malignant Fibrous Histiocytoma (MFH) Cohort Only | 2.5 | 95% Confidence Interval 1.4 to 5.5 | months | |
| Participants' Overall Survival (OS) | Liposarcoma Cohort Only | 18.6 | 95% Confidence Interval 5.2 to 27.7 | months | |
| Participants' Overall Survival (OS) | Leiomyosarcoma Cohort Only | 10.1 | 95% Confidence Interval 4.1 to 11.9 | months | |
| Participants' Overall Survival (OS) | Malignant Fibrous Histiocytoma (MFH) Cohort Only | 13.6 | 95% Confidence Interval 3.1 to 36.5 | months | |
| Number of Participants With Serious Adverse Events (SAEs) | Experimental: Sunitinib Malate (SU011248) Treatment | 13 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental: Sunitinib Malate (SU011248) Treatment | 48 | |
| Overall Study | COMPLETED | Experimental: Sunitinib Malate (SU011248) Treatment | 47 | |
| Overall Study | NOT COMPLETED | Experimental: Sunitinib Malate (SU011248) Treatment | 1 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anorexia | Metabolism and nutrition disorders | Experimental: Sunitinib Malate (SU011248) Treatment | 10 | 48 | 11 |
| other | Fatigue | General disorders | Experimental: Sunitinib Malate (SU011248) Treatment | 30 | 48 | 44 |
| other | Diarrhea | Gastrointestinal disorders | Experimental: Sunitinib Malate (SU011248) Treatment | 22 | 48 | 28 |
| other | Mucositis | Gastrointestinal disorders | Experimental: Sunitinib Malate (SU011248) Treatment | 18 | 48 | 22 |
| other | Vomiting | Gastrointestinal disorders | Experimental: Sunitinib Malate (SU011248) Treatment | 16 | 48 | 18 |
| other | Dysguesia | Gastrointestinal disorders | Experimental: Sunitinib Malate (SU011248) Treatment | 18 | 48 | 24 |
| other | Dyspepsia | Gastrointestinal disorders | Experimental: Sunitinib Malate (SU011248) Treatment | 21 | 48 | 22 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Experimental: Sunitinib Malate (SU011248) Treatment | 20 | 48 | 27 |
| other | Neutropenia | Blood and lymphatic system disorders | Experimental: Sunitinib Malate (SU011248) Treatment | 14 | 48 | 30 |
| other | Hypertension | Cardiac disorders | Experimental: Sunitinib Malate (SU011248) Treatment | 9 | 48 | 9 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: Sunitinib Malate (SU011248) Treatment | ||
| Total, other adverse events | Experimental: Sunitinib Malate (SU011248) Treatment | 39 | 48 |
| Total, serious adverse events | Experimental: Sunitinib Malate (SU011248) Treatment | 13 | 48 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00400569
GET https://conductscience.org/api/trials/v1/NCT00400569/events?page=2