Trial · NCT00464620

Trial of Dasatinib in Advanced Sarcomas

NCT00464620, Phase 2, Completed, Sarcoma Alliance for Research through Collaboration; results first posted 2018-11-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Dasatinib in Advanced Sarcomas. Trials, record NCT00464620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00464620

On this page

Trial

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

Title: Trial of Dasatinib in Advanced Sarcomas
NCT number: NCT00464620
Status: Completed
Phases: Phase 2
Enrollment: 366 participants, actual
Lead sponsor: Sarcoma Alliance for Research through Collaboration
Conditions: Rhabdomyosarcoma, Malignant Peripheral Nerve Sheath Tumors, Chondrosarcoma, Sarcoma, Ewing's, Sarcoma, Alveolar Soft Part, Chordoma, Epithelioid Sarcoma, Giant Cell Tumor of Bone, Hemangiopericytoma, Gastrointestinal Stromal Tumor (GIST)
Interventions: Dasatinib
First posted: 2007-04-23
Last updated: 2018-11-23
Results first posted: 2018-11-23

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Response Rate: Number of Participants With Objective Tumor Response	Up to 24 months	Assessment of objective tumor response for response rate with MRI or CT using Choi criteria: Complete Remission (CR) Complete disappearance of all measurable and evaluable disease for at least 4 weeks; Partial Remission (PR) A 10% or greater decrease from the baseline in the sum of the largest diameters of all measurable target lesions.
Primary	6 Month Progression-free Survival Rate of "Indolent" Sarcomas Treated With Dasatinib	At 6 months	Estimate the 6 month progression-free survival rate of "indolent" sarcomas treated with dasatinib. Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.
Primary	6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)	6 months	To estimate the 6 month progression-free survival rate of gastrointestinal stromal tumors (GIST). Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.
Secondary	Median Time-to-progression of Subjects With GIST Treated With Dasatinib.	Up to 30 months	To estimate the median time-to-progression of subjects with GIST treated with dasatinib.
Secondary	Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.	At 2 and 5 years	To estimate the overall survival rates at 2 and 5 years from registration of subjects treated with dasatinib.
Secondary	Median Time-to-progression of Subjects With "Indolent" Sarcomas Treated With Dasatinib.	Up to 24 months	To estimate the median time-to-progression of subjects with "indolent" sarcomas treated with dasatinib.
Secondary	6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.	At 6 months	To estimate the 6 month progression-free survival rate of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, Malignant fibrous histiocytoma (MFH), rhabdomyosarcoma and MPNST treated with dasatinib.
Secondary	Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.	Up to 37 weeks	To estimate the median time-to-progression of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, MFH, rhabdomyosarcoma and MPNST treated with dasatinib.
Secondary	Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.	At 2 and 5 years	To estimate the overall survival rates at 2 and 5 years from registration of subjects enrolled in the aggressive subtype treated with dasatinib.
Secondary	Uni-dimensional and Bi-dimensional Tumor Size, Tumor Volumes and Tumor Average Density Determined by Computer-aided Automated Detection in a Subset of Subjects With Tumor Predominately Involving the Lung	Up to 37 weeks	To prospectively collect uni-dimensional and bi-dimensional tumor size, tumor volumes and tumor average density determined by computer-aided automated detection in a subset of subjects with tumor predominately involving the lung

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response Rate: Number of Participants With Objective Tumor Response	Up to 24 months	116 subjects enrolled in the Indolent subtype, however 109 subjects began treatment. 50 patients enrolled in the GIST subtype, however 48 patients were evaluable. This explains the discrepancy between Overall Number of Participants Analyzed.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	6 Month Progression-free Survival Rate of Indolent Sarcomas Treated With Dasatinib	At 6 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)	6 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Time-to-progression of Subjects With GIST Treated With Dasatinib.	Up to 30 months		months	MEDIAN
SECONDARY	Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.	At 2 and 5 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Time-to-progression of Subjects With Indolent Sarcomas Treated With Dasatinib.	Up to 24 months		months	MEDIAN
SECONDARY	6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.	At 6 months	The numbers analyzed in one or more rows are different because they are broken up by cohorts.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.	Up to 37 weeks		months	MEDIAN
SECONDARY	Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.	At 2 and 5 years	The number analyzed in one or more rows differs from overall number because the rows are broken down into cohorts. The counts in the categories will not add up to the number analyzed, because those numbers represent number of participants that have reached overall survival at 2 and 5 years.	participants	NUMBER
SECONDARY	Uni-dimensional and Bi-dimensional Tumor Size, Tumor Volumes and Tumor Average Density Determined by Computer-aided Automated Detection in a Subset of Subjects With Tumor Predominately Involving the Lung	Up to 37 weeks	This data was not collected because the imaging software and work station was not obtained.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group39

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

Outcome	Group	Category	Value	Spread	Units
Response Rate: Number of Participants With Objective Tumor Response	GIST: Dasatinib, 70 mg, Twice Daily		12		Participants
Response Rate: Number of Participants With Objective Tumor Response	Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily		14		Participants
Response Rate: Number of Participants With Objective Tumor Response	Indolent Subtype: Dasatinib, 70 mg, Twice Daily		20		Participants
6 Month Progression-free Survival Rate of Indolent Sarcomas Treated With Dasatinib	Indolent Subtypes: Dasatinib, 70 mg, Twice Daily		52		Participants
6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)	GIST: Dasatinib, 70 mg, Twice Daily		14		Participants
Median Time-to-progression of Subjects With GIST Treated With Dasatinib.	GIST: Dasatinib, 70 mg, Twice Daily		2.9	Full Range 2 to 5.5	months
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.	GIST: Dasatinib, 70 mg, Twice Daily	2 years overall survival	21		Participants
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.	Indolent Subtype: Dasatinib, 70 mg, Twice Daily	2 years overall survival	48		Participants
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.	GIST: Dasatinib, 70 mg, Twice Daily	5 years overall survival	8		Participants
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.	Indolent Subtype: Dasatinib, 70 mg, Twice Daily	5 years overall survival	14		Participants

1 to 10 of 39Source ClinicalTrials.gov

See all 39 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	GIST: Dasatinib, 70 mg, Twice Daily	50
Overall Study	STARTED	Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily	200
Overall Study	STARTED	Indolent Subtype: Dasatinib, 70 mg, Twice Daily	116
Overall Study	COMPLETED	GIST: Dasatinib, 70 mg, Twice Daily	48
Overall Study	COMPLETED	Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily	198
Overall Study	COMPLETED	Indolent Subtype: Dasatinib, 70 mg, Twice Daily	109
Overall Study	NOT COMPLETED	GIST: Dasatinib, 70 mg, Twice Daily	2
Overall Study	NOT COMPLETED	Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily	2
Overall Study	NOT COMPLETED	Indolent Subtype: Dasatinib, 70 mg, Twice Daily	7

Source ClinicalTrials.gov

Adverse events236

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	GIST, Aggressive, Indolent Subtypes	45	355	49
other	Constipation	Gastrointestinal disorders	GIST, Aggressive, Indolent Subtypes	27	355	27
other	Cough	Respiratory, thoracic and mediastinal disorders	GIST, Aggressive, Indolent Subtypes	45	355	55
other	Diarrhea	Gastrointestinal disorders	GIST, Aggressive, Indolent Subtypes	73	355	99
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	GIST, Aggressive, Indolent Subtypes	56	355	78
other	Edema	General disorders	GIST, Aggressive, Indolent Subtypes	34	355	50
other	Fatigue	General disorders	GIST, Aggressive, Indolent Subtypes	113	355	144
other	Fever	General disorders	GIST, Aggressive, Indolent Subtypes	27	355	29
other	Hyperglycemia	Metabolism and nutrition disorders	GIST, Aggressive, Indolent Subtypes	25	355	41
other	Nausea	Gastrointestinal disorders	GIST, Aggressive, Indolent Subtypes	81	355	93

1 to 10 of 236Source ClinicalTrials.gov

See all 236 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GIST, Aggressive, Indolent Subtypes
Total, other adverse events	GIST, Aggressive, Indolent Subtypes	314	355
Total, serious adverse events	GIST, Aggressive, Indolent Subtypes	158	355

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.

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/NCT00464620

GET https://conductscience.org/api/trials/v1/NCT00464620/results?page=2

API reference For AI assistants