Trial Outcomes & Findings for Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors (NCT NCT00859937)

Last Updated: 2018-04-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

Up to 2 months

Results posted on

2018-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Adenoid Cystic Carcinoma 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.	Non Adenoid Cystic Carcinoma 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.
Overall Study STARTED	41	14
Overall Study COMPLETED	40	14
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Adenoid Cystic Carcinoma 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.	Non Adenoid Cystic Carcinoma 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.
Overall Study Protocol Violation	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adenoid Cystic Carcinoma n=40 Participants 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.	Non Adenoid Cystic Carcinoma n=14 Participants 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.	Total n=54 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	56 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	4 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 months

Population: 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.

Outcome measures

Outcome measures
Measure	Adenoid Cystic Carcinoma n=40 Participants 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.	Non Adenoid Cystic Carcinoma n=14 Participants 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.
Response Rate Complete response	0 participants	0 participants
Response Rate Partial response	1 participants	0 participants
Response Rate Stable disease	20 participants	7 participants
Response Rate Progressive disease	12 participants	4 participants
Response Rate Other	7 participants	3 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adenoid Cystic Carcinoma n=40 Participants 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.	Non Adenoid Cystic Carcinoma n=14 Participants 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.
Progression-free Survival	4.8 months Interval 1.9 to 5.5	2.7 months Interval 1.8 to 5.5

SECONDARY outcome

Timeframe: Up to 5 years

Kaplan-Meier curves will be generated and 90% confidence intervals will be derived.

Outcome measures

Outcome measures
Measure	Adenoid Cystic Carcinoma n=40 Participants 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.	Non Adenoid Cystic Carcinoma n=14 Participants 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.
Overall Survival	14.5 months Interval 8.8 to 31.7	4.8 months Interval 2.2 to 8.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Biomarkers not done due to insufficient clinical responses thus making the biomarker analysis scientifically untenable.

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.

Outcome measures

Outcome data not reported

Adverse Events

Adenoid Cystic Carcinoma

Serious events: 12 serious events

Other events: 39 other events

Deaths: 0 deaths

Non Adenoid Cystic Carcinoma

Serious events: 8 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Stuart Wong

University of Chicago Comprehensive Cancer Center

Phone: 773-702-9311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Adenoid Cystic Carcinoma n=40 participants at risk 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.	Non Adenoid Cystic Carcinoma n=14 participants at risk 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.
Investigations Alanine aminotransferase increased	2.5% 1/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	0.00% 0/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Metabolism and nutrition disorders Anorexia	2.5% 1/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	7.1% 1/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Nervous system disorders Cauda equina syndrome	2.5% 1/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	0.00% 0/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Cardiac disorders Chest pain	0.00% 0/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	7.1% 1/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Psychiatric disorders Confusion	0.00% 0/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	7.1% 1/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	5.0% 2/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	7.1% 1/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Gastrointestinal disorders Dysphagia	0.00% 0/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	7.1% 1/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.5% 3/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	7.1% 1/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Metabolism and nutrition disorders Hyperglycemia	2.5% 1/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	0.00% 0/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	7.1% 1/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Infections and infestations Infections and infestations	2.5% 1/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	0.00% 0/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Eye disorders Loss of vision	2.5% 1/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	0.00% 0/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Gastrointestinal disorders Nausea	2.5% 1/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	0.00% 0/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
General disorders Non-cardiac chest pain	0.00% 0/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	7.1% 1/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.5% 1/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	0.00% 0/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.5% 1/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	0.00% 0/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Vascular disorders Thromboembolic event	0.00% 0/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	7.1% 1/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
Skin and subcutaneous tissue disorders Urticaria	2.5% 1/40 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.	0.00% 0/14 • Up to 5 years All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.