TriangleNCT00859937 · STUDY IN CONTEXT
Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
Kaplan-Meier curves will be generated and 90% confidence intervals will be derived.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- trial label
- Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0000
- source section id
- NCT00859937-om-0000
- source outcome index
- 0
- endpoint
- Response Rate
- endpoint definition
- 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.
- time origin
- Up to 2 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0001
- source section id
- NCT00859937-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival
- endpoint definition
- 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.
- time origin
- up to 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0002
- source section id
- NCT00859937-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- Kaplan-Meier curves will be generated and 90% confidence intervals will be derived.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0003
- source section id
- NCT00859937-om-0003
- source outcome index
- 3
- endpoint
- Changes in Laboratory Correlates
- endpoint definition
- 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.
- time origin
- Baseline and 4 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Biomarkers not done due to insufficient clinical responses thus making the biomarker analysis scientifically untenable.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Adenoid Cystic Carcinoma
- regimen
- Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00859937-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Non Adenoid Cystic Carcinoma
- regimen
- Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00859937-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Adenoid Cystic Carcinoma
- regimen
- Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00859937-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Non Adenoid Cystic Carcinoma
- regimen
- Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00859937-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Adenoid Cystic Carcinoma
- regimen
- Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00859937-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Non Adenoid Cystic Carcinoma
- regimen
- Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00859937-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Adenoid Cystic Carcinoma
- regimen
- Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00859937-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Non Adenoid Cystic Carcinoma
- regimen
- Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00859937-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- harm key
- EG000
- source section id
- NCT00859937-ae
- event group key
- EG000
- event group label
- Adenoid Cystic Carcinoma
- serious affected
- 12
- serious at risk
- 40
- other affected
- 39
- other at risk
- 40
- frequency threshold
- 5
- collection period
- Up to 5 years
- event definition
- All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer
- nct id
- NCT00859937
- harm key
- EG001
- source section id
- NCT00859937-ae
- event group key
- EG001
- event group label
- Non Adenoid Cystic Carcinoma
- serious affected
- 8
- serious at risk
- 14
- other affected
- 13
- other at risk
- 14
- frequency threshold
- 5
- collection period
- Up to 5 years
- event definition
- All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice