Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery
A Phase II Trial of Dasatinib in KIT-Positive Patients With Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas
2 other identifiers
interventional
81
1 country
153
Brief Summary
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with locally advanced or metastatic mucosal melanoma or acral melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2009
Longer than P75 for phase_2
153 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedStudy Start
First participant enrolled
July 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2016
CompletedResults Posted
Study results publicly available
February 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2020
CompletedJuly 3, 2023
June 1, 2023
6.8 years
June 18, 2008
December 31, 2019
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate Among KIT-positive Patients
Objective response is defined as complete response (CR) or partial response (PR) per Solid Tumor Response Criteria (RECIST). Complete response is defined as disappearance of all target and non-target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
Every 6 weeks; up to 5 years
Secondary Outcomes (2)
Duration of Response for Dasatinib Monotherapy in This Patient Population
Every 6 weeks; up to 5 years
Progression-free Survival
Every 6 weeks; up to 5 years
Other Outcomes (1)
To Evaluate the PDGFR Expression, and Activation of Src Family Kinases in Tumor Samples and Correlate These Parameters With Response to Treatment.
Every 6 weeks; up to 5 years
Study Arms (1)
Dasatinib
EXPERIMENTALPatients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed melanoma of 1 of the following subtypes:
- Acral melanoma (defined as occurring on the palms, soles, or subungual sites)
- Melanoma arising from the vagina and/or vulva
- Melanoma arising on other mucosal surface (not vagina or vulva)
- Unresectable locally advanced or metastatic disease
- c-KIT mutation identified by polymerase chain reaction (PCR) and sequencing meeting 1 of the following criteria:
- At least 1 mutation in exon 9, 11, 13, 17, or 18
- At least 1 mutation in an exon not listed above and approved by central reviewer
- Metastatic tumor blocks are required for the evaluation of KIT mutations or amplifications
- Prior radiotherapy to a measurable lesion allowed provided there is radiographic evidence of progression of that lesion
- No other concurrent malignancies except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, or other malignancies from which the patient has been continuously disease-free for ≥ 5 years
- ECOG performance status 0-1
You may not qualify if:
- Prior treatment with targeted therapies directed to c-KIT/PDGFR (e.g., imatinib or sunitinib)
- Ocular melanoma
- Evidence of bleeding diathesis
- Clinically significant psychiatric illness or social situations that would limit compliance with study requirements
- Clinically significant cardiovascular disease including the following:
- Myocardial infarction or ventricular tachyarrhythmia within 6 months
- Prolonged QTc \>480 msec (Fridericia correction)
- Ejection fraction less than institutional normal
- Major conduction abnormality (unless a cardiac pacemaker is present)
- Patients with any cardiopulmonary symptoms of unknown cause (e.g., shortness of breath, chest pain, etc.) are to be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out QTc prolongation
- Patients with underlying cardiopulmonary dysfunction are excluded from the study
- Meeting the eligibility criteria for pre-registration (Step 0)
- The melanoma must harbor a c-KIT mutation determined by PCR and sequencing as defined in the protocol either by local assessment or Massachusetts General Hospital (MGH)
- Measurable disease, defined as at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- At least 4 weeks since prior chemotherapy, radiotherapy or immunotherapy and the beginning of protocol therapy and the patient must have recovered from toxicity due to the previous therapy
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (153)
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Stanford Cancer Center
Stanford, California, 94305-5824, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, 32803-1273, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, 96813, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, 96813, United States
Kuakini Medical Center
Honolulu, Hawaii, 96817, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Castle Medical Center
Kailua, Hawaii, 96734, United States
Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, 96701, United States
Oncare Hawaii, Incorporated - Pali Momi
‘Aiea, Hawaii, 96701, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, 61265, United States
Unknown Facility
Moline, Illinois, 61265, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289, United States
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, 46202, United States
William N. Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Unknown Facility
Bettendorf, Iowa, 52722, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51102, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's Hospital - South
Overland Park, Kansas, 66213, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
CCOP - Kansas City
Prairie Village, Kansas, 66208, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, 21204, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology - Woodbury
Woodbury, Minnesota, 55125, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology Oncology Associates, Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Parvin Radiation Oncology
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Saint Joseph Oncology, Incorporated
Saint Joseph, Missouri, 64507, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59102, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, 58502, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Barberton Citizens Hospital
Barberton, Ohio, 44203, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, 54701, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, 54221-1450, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, 54548, United States
D.N. Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, 54868, United States
St. Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Related Publications (2)
Kalinsky K, Lee S, Rubin KM, Lawrence DP, Iafrarte AJ, Borger DR, Margolin KA, Leitao MM Jr, Tarhini AA, Koon HB, Pecora AL, Jaslowski AJ, Cohen GI, Kuzel TM, Lao CD, Kirkwood JM. A phase 2 trial of dasatinib in patients with locally advanced or stage IV mucosal, acral, or vulvovaginal melanoma: A trial of the ECOG-ACRIN Cancer Research Group (E2607). Cancer. 2017 Jul 15;123(14):2688-2697. doi: 10.1002/cncr.30663. Epub 2017 Mar 23.
PMID: 28334439RESULTKalinsky K, Hong F, McCourt CK, Sachdev JC, Mitchell EP, Zwiebel JA, Doyle LA, McShane LM, Li S, Gray RJ, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Conley BA, O'Dwyer PJ, Harris LN, Arteaga CL, Chen AP, Flaherty KT. Effect of Capivasertib in Patients With an AKT1 E17K-Mutated Tumor: NCI-MATCH Subprotocol EAY131-Y Nonrandomized Trial. JAMA Oncol. 2021 Feb 1;7(2):271-278. doi: 10.1001/jamaoncol.2020.6741.
PMID: 33377972DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- STUDY CHAIR
Donald P. Lawrence, MD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Kevin Kalinsky, MD
Tufts Medical Center Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 19, 2008
Study Start
July 2, 2009
Primary Completion
May 6, 2016
Study Completion
December 28, 2020
Last Updated
July 3, 2023
Results First Posted
February 24, 2020
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.