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Trial · NCT00859937

Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors

NCT00859937, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-04-03

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors. Trials, record NCT00859937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00859937

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Trial

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

Title
Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors
NCT number
NCT00859937
Status
Completed
Phases
Phase 2
Enrollment
55 participants, actual
Lead sponsor
National Cancer Institute (NCI)
Conditions
Malignant Salivary Gland Neoplasm, Recurrent Salivary Gland Carcinoma, Salivary Gland Adenoid Cystic Carcinoma, Stage IV Major Salivary Gland Cancer AJCC v7
Interventions
Dasatinib, Laboratory Biomarker Analysis
First posted
2009-03-11
Last updated
2018-04-20
Results first posted
2015-04-03

Source ClinicalTrials.gov

Registered outcomes4

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

ListOutcomeTime frameDescription
PrimaryResponse RateUp to 2 months
Response rate is percentage of the best overall response which recoded from the start of the treatment until diseases progression/recurrence. Response criteria are defined using the international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
PrimaryProgression-free Survivalup to 5 yearsProgression-free survival from start of treatment to the time of disease progression or death from any cause was estimated using the Kaplan-Meier method.
SecondaryOverall SurvivalUp to 5 yearsKaplan-Meier curves will be generated and 90% confidence intervals will be derived.
SecondaryChanges in Laboratory CorrelatesBaseline and 4 weeks
Changes in laboratory correlates pre-post therapy will be analyzed using paired t-tests. The association between RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorp response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as cova only due to the small sample size) in a Cox regression model of progression-free survival.

Outcomes4

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYResponse RateUp to 2 months
There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.
participantsNUMBER
PRIMARYProgression-free Survivalup to 5 years
There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.
monthsMEDIAN
SECONDARYOverall SurvivalUp to 5 years
There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.
monthsMEDIAN
SECONDARYChanges in Laboratory CorrelatesBaseline and 4 weeksBiomarkers not done due to insufficient clinical responses thus making the biomarker analysis scientifically untenable.

Results by group14

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

OutcomeGroupCategoryValueSpreadUnits
Response RateAdenoid Cystic CarcinomaComplete response0participants
Response RateNon Adenoid Cystic CarcinomaComplete response0participants
Response RateAdenoid Cystic CarcinomaPartial response1participants
Response RateNon Adenoid Cystic CarcinomaPartial response0participants
Response RateAdenoid Cystic CarcinomaStable disease20participants
Response RateNon Adenoid Cystic CarcinomaStable disease7participants
Response RateAdenoid Cystic CarcinomaProgressive disease12participants
Response RateNon Adenoid Cystic CarcinomaProgressive disease4participants
Response RateAdenoid Cystic CarcinomaOther7participants
Response RateNon Adenoid Cystic CarcinomaOther3participants

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDAdenoid Cystic Carcinoma41
Overall StudySTARTEDNon Adenoid Cystic Carcinoma14
Overall StudyCOMPLETEDAdenoid Cystic Carcinoma40
Overall StudyCOMPLETEDNon Adenoid Cystic Carcinoma14
Overall StudyNOT COMPLETEDAdenoid Cystic Carcinoma1
Overall StudyNOT COMPLETEDNon Adenoid Cystic Carcinoma0

Adverse events206

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAbdominal distensionGastrointestinal disordersAdenoid Cystic Carcinoma040
otherAbdominal distensionGastrointestinal disordersNon Adenoid Cystic Carcinoma114
otherActivated partial thromboplastin time prolongedInvestigationsAdenoid Cystic Carcinoma040
otherActivated partial thromboplastin time prolongedInvestigationsNon Adenoid Cystic Carcinoma114
otherAlanine aminotransferase increasedInvestigationsAdenoid Cystic Carcinoma1040
otherAlanine aminotransferase increasedInvestigationsNon Adenoid Cystic Carcinoma414
otherAlkaline phosphatase increasedInvestigationsAdenoid Cystic Carcinoma740
otherAlkaline phosphatase increasedInvestigationsNon Adenoid Cystic Carcinoma014
otherAllergic reactionImmune system disordersAdenoid Cystic Carcinoma240
otherAllergic reactionImmune system disordersNon Adenoid Cystic Carcinoma014

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityAdenoid Cystic Carcinoma
Total, all-cause mortalityNon Adenoid Cystic Carcinoma
Total, other adverse eventsAdenoid Cystic Carcinoma3940
Total, other adverse eventsNon Adenoid Cystic Carcinoma1314
Total, serious adverse eventsAdenoid Cystic Carcinoma1240
Total, serious adverse eventsNon Adenoid Cystic Carcinoma814

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
P30CA014599Cancer Center Support GrantODUNSI, KUNLEUNIVERSITY OF CHICAGONATIONAL CANCER INSTITUTE1985 to 2025

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Adenoid Cystic Carcinoma vs Non Adenoid Cystic Carcinoma: serious adverse events

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/NCT00859937

GET https://conductscience.org/api/trials/v1/NCT00859937/events?page=2