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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | Up 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. |
| Primary | Progression-free Survival | up to 5 years | Progression-free survival from start of treatment to the time of disease progression or death from any cause was estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival | Up to 5 years | Kaplan-Meier curves will be generated and 90% confidence intervals will be derived. |
| Secondary | Changes in Laboratory Correlates | Baseline 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. |
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 | Response Rate | Up 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. | participants | NUMBER |
| PRIMARY | Progression-free Survival | up 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. | months | MEDIAN |
| SECONDARY | Overall Survival | Up 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. | months | MEDIAN |
| SECONDARY | Changes in Laboratory Correlates | Baseline and 4 weeks | Biomarkers not done due to insufficient clinical responses thus making the biomarker analysis scientifically untenable. |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Adenoid Cystic Carcinoma | Complete response | 0 | participants | |
| Response Rate | Non Adenoid Cystic Carcinoma | Complete response | 0 | participants | |
| Response Rate | Adenoid Cystic Carcinoma | Partial response | 1 | participants | |
| Response Rate | Non Adenoid Cystic Carcinoma | Partial response | 0 | participants | |
| Response Rate | Adenoid Cystic Carcinoma | Stable disease | 20 | participants | |
| Response Rate | Non Adenoid Cystic Carcinoma | Stable disease | 7 | participants | |
| Response Rate | Adenoid Cystic Carcinoma | Progressive disease | 12 | participants | |
| Response Rate | Non Adenoid Cystic Carcinoma | Progressive disease | 4 | participants | |
| Response Rate | Adenoid Cystic Carcinoma | Other | 7 | participants | |
| Response Rate | Non Adenoid Cystic Carcinoma | Other | 3 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adenoid Cystic Carcinoma | 41 | |
| Overall Study | STARTED | Non Adenoid Cystic Carcinoma | 14 | |
| Overall Study | COMPLETED | Adenoid Cystic Carcinoma | 40 | |
| Overall Study | COMPLETED | Non Adenoid Cystic Carcinoma | 14 | |
| Overall Study | NOT COMPLETED | Adenoid Cystic Carcinoma | 1 | |
| Overall Study | NOT COMPLETED | Non Adenoid Cystic Carcinoma | 0 |
Source ClinicalTrials.gov
Adverse events206
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 | Abdominal distension | Gastrointestinal disorders | Adenoid Cystic Carcinoma | 0 | 40 | |
| other | Abdominal distension | Gastrointestinal disorders | Non Adenoid Cystic Carcinoma | 1 | 14 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Adenoid Cystic Carcinoma | 0 | 40 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Non Adenoid Cystic Carcinoma | 1 | 14 | |
| other | Alanine aminotransferase increased | Investigations | Adenoid Cystic Carcinoma | 10 | 40 | |
| other | Alanine aminotransferase increased | Investigations | Non Adenoid Cystic Carcinoma | 4 | 14 | |
| other | Alkaline phosphatase increased | Investigations | Adenoid Cystic Carcinoma | 7 | 40 | |
| other | Alkaline phosphatase increased | Investigations | Non Adenoid Cystic Carcinoma | 0 | 14 | |
| other | Allergic reaction | Immune system disorders | Adenoid Cystic Carcinoma | 2 | 40 | |
| other | Allergic reaction | Immune system disorders | Non Adenoid Cystic Carcinoma | 0 | 14 |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adenoid Cystic Carcinoma | ||
| Total, all-cause mortality | Non Adenoid Cystic Carcinoma | ||
| Total, other adverse events | Adenoid Cystic Carcinoma | 39 | 40 |
| Total, other adverse events | Non Adenoid Cystic Carcinoma | 13 | 14 |
| Total, serious adverse events | Adenoid Cystic Carcinoma | 12 | 40 |
| Total, serious adverse events | Non Adenoid Cystic Carcinoma | 8 | 14 |
Source ClinicalTrials.gov
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA014599 | Cancer Center Support Grant | ODUNSI, KUNLE | UNIVERSITY OF CHICAGO | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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 |
Source Trial comparisons
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/NCT00859937
GET https://conductscience.org/api/trials/v1/NCT00859937/events?page=2