Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 25 February 2013
• Main ID: NCT01092728
• Date of registration: 23/03/2010
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma
• Scientific title: A Phase II Study of Biological Response to Dasatinib Treatment in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma
• Date of first enrolment: March 2011
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01092728
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Kevin B. Kim, MD, BA

• Name: Kevin B. Kim, MD, BA
• Affiliation: UT MD Anderson Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients must have primary, recurrent or metastatic melanoma with one of the
following pathology or characteristics: i) acral lentiginous melanoma ii) mucosal
melanoma iii) any known KIT mutation.

2. (Continued 1) If 20 patients without tumors harboring exon 11 or 13 KIT mutation are
enrolled and treated before the completion of the patient accrual of 30, only those
with tumors harboring exon 11 or 13 KIT mutation will be enrolled. Likewise, if 10
patients with tumors harboring exon 11 or 13 KIT mutation are enrolled and treated
before the completion of the patient accrual of 30, only those without tumors
harboring exon 11 or 13 KIT mutation will then be enrolled.

3. Patients must have measurable disease by FDG-PET (with or without CT) defined as
having a SUVmax of 3 and SUVmax ofat least 2 fold greater than background.

4. Patients scheduled for FDG-PET should have uptake of the tracer in at least one
lesion (tumor-to-muscle ratio >2) in the baseline PET/CT scan in order to be eligible
for the follow-up FDG PET scans.

5. Patient must have surgically resectable melanoma lesion(s) or biopsiable lesion(s)
which are amenable to 2 separate biopsy procedures by a core needle or excision.

6. Age >/= 18 years.

7. ECOG performance status 0 or 1.

8. Adequate Organ Function: a. Total bilirubin < 2.0 times the institutional Upper Limit
of Normal (ULN), b.Hepatic enzymes (AST, ALT ) c. Serum Creatinine < 1.5 time the institutional ULN, d.Neutrophil count >/= 1500;
Platelets >/= 75,000;

9. Ability to take oral medication (dasatinib must be swallowed whole)

10. Concomitant Medications: a. Patient agrees to discontinue St. Johns Wort while
receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before
starting dasatinib), b.Patient agrees that IV bisphosphonates will be withheld for
the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.

11. Women of childbearing potential (WOCBP) must have: a) A negative serum or urine
pregnancy test (sensitivity 25 IU HCG/L) within 72 hours prior to the start of study
drug administration b) Persons of reproductive potential must agree to use and
utilize an adequate method of contraception throughout treatment and for at least 4
weeks after study drug is stopped. Prior to study enrollment, women of childbearing
potential must be advised of the importance of avoiding pregnancy during trial
participation and the potential risk factors for an unintentional pregnancy.

12. Signed written informed consent including a HIPAA form according to institutional
guidelines

Exclusion Criteria:

1. No other malignancy which required radiotherapy or systemic treatment within the past
5 years.

2. Concurrent medical condition which may increase the risk of toxicity, including: a.
Pleural or pericardial effusion of any grade.

3. Cardiac Symptoms; any of the following should be considered for exclusion: a.
Uncontrolled angina, congestive heart failure or MI within (6 months), b. Diagnosed
congenital long QT syndrome, c. Any history of clinically significant ventricular
arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades
de pointes), d. Prolonged QTc interval on pre-entry electrocardiogram (> 480 msec)
[or > 500 msec for patients with a bundle branch block]), e. Subjects with
hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib
administration.

4. History of significant bleeding disorder unrelated to cancer, including: a. Diagnosed
congenital bleeding disorders (e.g., von Willebrand's disease), b. Diagnosed acquired
bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies), c.
Ongoing or recent (
5. Concomitant Medications, any of the following should be considered for exclusion: a.
Category I drugs that are generally accepted to have a risk of causing Torsades de
Pointes including: (Patients must discontinue drug 7 days prior to starting
dasatinib), I. quinidine, procainamide, disopyramide, II. amiodarone, sotalol,
ibutilide, dofetilide, III. erythromycin, clarithromycin, IV. chlorpromazine,
haloperidol, mesoridazine, thioridazine, pimozide V. cisapride, bepridil, droperidol,
methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl,
pentamidine, sparfloxacin, lidoflazine.

6. Women who: a. are unwilling or unable to use an acceptable method to avoid pregnancy
for the entire study period and for at least 4 weeks after cessation of study drug,
or, b. have a positive pregnancy test at baseline, or, c. are pregnant or
breastfeeding,

7. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious) illness

8. No active, untreated brain metastases. Patients with known brain metastases will be
included if the brain metastases have been treated and stable for at least 3 months
without the use of steroid

9. HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with dasatinib. In addition, these
patients are at increased risk of lethal infections when treated with
marrow-suppressive therapy. Appropriate studies will be undertaken in patients
receiving combination antiretroviral therapy when indicated.

10. Patients with melanoma harboring BRAF mutation. If BRAF mutation is not known at the
time of screening, patients will still be eligible



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Melanoma

Intervention(s)

Drug: Dasatinib

Primary Outcome(s)

Comparison of Biologic Response of Patient Tumors with and without Exon 11 or 13 KIT Mutations [Time Frame: Baseline to 7 Days]

Secondary ID(s)

2009-0447

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb