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Malignant Salivary Gland NeoplasmPhase 2NCT00859937

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

A Phase 2 study testing Dasatinib and Laboratory Biomarker Analysis in people with Malignant Salivary Gland Neoplasm and Recurrent Salivary Gland Carcinoma, run by National Cancer Institute (NCI) at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase II trial is studying how well dasatinib works in treating patients with malignant salivary gland tumors that have come back after treatment or have spread to other parts of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dasatinib and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
34 sitesin 2 countries
Study dates
16 Mar 2009to 30 Jan 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed malignant salivary gland tumor (MSGT), including one of the following histologic subtypes:
  • Adenoid cystic carcinoma (ACC) with c v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (Kit) overexpression or non-ACC MSGT that is not amenable to potentially curable surgery or radiation
  • c-KIT overexpression in ACC patients is defined as cluster of differentiation (CD) 117 staining by immunohistochemistry (IHC) in 25% of tumor cells
  • No stipulation for c-KIT overexpression is not required for non-ACC MSGT patients
  • Patients must have radiographically measurable disease; radiographically measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan
  • Patients must have evidence of disease progression (objective growth of existing tumors) within 4 months of study entry
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  • No known brain metastases, unless patient meets both of the following criteria:
  • Neurologic status stable for >= 8 weeks after completion of definitive local therapy (surgery or radiotherapy)
  • No neurologic dysfunction that would confound study results
  • Life expectancy greater than 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 OR Karnofsky performance status (PS) >= 60%
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelet >= 100,000/mcL
  • Hemoglobin >= 9 g/dL
  • Serum calcium =< 12.0 mg/dL
  • Total serum bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; all women of childbearing potential must have a negative pregnancy test prior to receiving dasatinib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; at least 4 weeks must have elapsed since any major surgery
  • Patients may not be receiving any other investigational agents
  • No prior treatment with any other targeted agents that inhibit vascular endothelial growth factor receptor (VEGFR), Breakpoint cluster region (BCR) ABL proto-oncogene 1, non-receptor tyrosine kinase (ABL), c-Src, c-KIT, platelet-derived growth factor (PDGF) beta receptor, or ephrin type-A receptor 2 (EPHA2) (e.g., imatinib mesylate)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib
  • Patients with corrected QT interval (QTc) prolongation (defined as a QTc interval equal to or greater than 500 msec), serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia greater than or equal to 3 beats in a row) or other significant echocardiogram (ECG) abnormalities are excluded
  • Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for intravenous [IV] alimentation, or active peptic ulcer disease) that impairs their ability to swallow and retain dasatinib tablets are excluded
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  • Patients with any of the following conditions are excluded:
  • Serious or non-healing wound, ulcer, or bone fracture
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscesses within the past 28 days
  • Any history of cerebrovascular accident (CVA) or transient ischemic attack within the past 12 months
  • History of myocardial infraction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 6 months
  • History of pulmonary embolism within the past 12 months
  • Ejection fraction less than institutional normal by echocardiograph (only required for patients with a known history of congestive heart failure, low ejection fraction, or clinical symptoms/findings consistent with congestive heart failure)
  • Patients taking medications that are potent inducers or inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) liver enzyme will be determined following a review of their case by the Principal Investigator; every effort should be made to switch patients taking such agents or substances to other medications
  • Patients with known brain metastases should be excluded; patients with brain metastases with stable neurologic status following local therapy (surgery or radiation) for at least 8 weeks from definitive therapy and without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events are eligible for participation; patients cannot be receiving enzyme inducing anti-convulsants including carbamazepine, phenobarbital, and phenytoin
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements are ineligible
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with dasatinib
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
  • Patients who have an active pleural or pericardial effusion of any grade
  • Diagnosis of any second malignancy within the last 5 years; basal cell carcinoma, squamous cell skin cancer, stage I carcinoma fully treated, or in situ carcinoma that have been adequately treated with no evidence of recurrent disease for 12 months will be eligible

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States31 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211-1850

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Mercy UC Davis Cancer Center

    Merced, California, 95340

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Mount Sinai Hospital

    New York, New York, 10029

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Oncology Care Associates PLLC

    Saint Joseph, Michigan, 49085

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 62702

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center-Wakefield Campus

    The Bronx, New York, 10466

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

Other trials in United States

Canada3 sites

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • CHUM-Hotel Dieu de Montreal

    Montreal, Quebec, H2W 1T8

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Phase II Trial of Dasatinib (BMS 354825) for Recurrent or Metastatic c-KIT Expressing Adenoid Cystic Carcinoma and Non-adenoid Cystic Malignant Salivary Tumors

This phase II trial is studying how well dasatinib works in treating patients with malignant salivary gland tumors that have come back after treatment or have spread to other parts of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the objective response rate (complete response plus partial response) of dasatinib in adenoid cystic carcinoma (ACC).

II. Determine the progression-free survival of dasatinib in ACC.

SECONDARY OBJECTIVES:

  1. Determine the duration of response. II. Determine the stable disease rate and duration of stable disease. III. Determine progression-free survival. IV. Determine the median survival. V. Determine the overall survival. VI. Determine the safety and tolerability.

TERTIARY OBJECTIVES:

  1. To examine biomarkers that relate to SRC proto-oncogene, non-receptor tyrosine kinase (Src) signal transduction and to correlate these biomarkers with clinical response to dasatinib in ACC and non-ACC malignant salivary gland tumors (MSGT).

II. Determine if activating mutations in platelet-derived growth factor alpha polypeptide (PDGFA) and KIT are associated with response in ACC.

OUTLINE:

Patients receive dasatinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed at 8 weeks.

Being tested
Dasatinib, Laboratory Biomarker Analysis
Medical subject headings
Salivary Gland Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasatinibDrug

    Also called BMS-354825, Sprycel

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00859937
Study groupRoleWhat they receive
Arm IExperimentalPatients receive dasatinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Dasatinib; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate

    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.

    Measured: Up to 2 months

  2. Progression-free Survival

    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.

    Measured: up to 5 years

Secondary outcomes (2)

  1. Overall Survival

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

    Measured: Up to 5 years

  2. Changes in Laboratory Correlates

    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.

    Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2009 (estimated)
  2. Study start16 Mar 2009
  3. Primary completion30 Jan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00859937
Sponsor's protocol ID
NCI-2009-01165
Other IDs
NCI-2009-01165, CDR0000636685, UCCRC-16691B, 16691B, 8271, N01CM00032, N01CM00038, N01CM00071
Status last verified
Mar 2018
First submitted
10 Mar 2009
Last updated
20 Apr 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib and Laboratory Biomarker Analysis in people with Malignant Salivary Gland Neoplasm and Recurrent Salivary Gland Carcinoma, run by National Cancer Institute (NCI) at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: Up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00859937.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.

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