Study Stopped
Administratively complete.
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma
Phase II Study of RO4929097 (NSC-749225) in Advanced Melanoma
5 other identifiers
interventional
36
1 country
178
Brief Summary
This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with stage IV melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2010
Longer than P75 for phase_2
178 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
May 7, 2010
CompletedFirst Posted
Study publicly available on registry
May 10, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
June 14, 2016
CompletedJune 14, 2016
May 1, 2016
2.6 years
May 7, 2010
October 29, 2015
May 6, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.
Disease assessments were performed every 6 weeks, up to 3 years.
Overall Survival
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Weekly, up to 3 years.
Secondary Outcomes (2)
Percentage of Participants With Confirmed and Unconfirmed Complete or Partial Response
Disease assessments for response were performed every 6 weeks, up to 3 years
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years
Study Arms (1)
Treatment (gamma-secretase inhibitor RO4929097)
EXPERIMENTALPatients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Correlative studies
Eligibility Criteria
You may qualify if:
- Patients must have histologically confirmed melanoma of cutaneous or unknown origin (ocular primary and mucosal primary excluded); patients must have Stage IV disease
- All patients must undergo a computed tomography (CT) or magnetic resonance imaging (MRI) of the brain within 42 days prior to registration that is negative for brain metastases; patients with a history of brain metastases are ineligible
- Patients must have measurable disease; all measurable lesions must be assessed (by physical examination, CT, or MRI scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1); the CT from a combined positron emission tomography (PET)/CT must not be used to document measurable disease unless it is of diagnostic quality
- Sites must offer all patients participation in translational medicine studies and banking of paraffin embedded tissue and whole blood
- Patients must not have received any prior systemic therapy for Stage IV disease except for noncytotoxic biologic agents (e.g., vaccines, cytokines, cell therapies that do not require cytotoxic agents); patients may have received prior treatment with up to two prior biological therapies - no cytotoxics or kinase inhibitors - for advanced disease
- Patients may have had prior adjuvant immunotherapy with biological response modifiers (examples include but are not limited to interferon, vaccines, GM-CSF, and CTLA-4 blocking antibodies); prior adjuvant immunotherapy must have been completed at least 28 days prior to registration
- Adjuvant therapy containing cytotoxic agents is allowed if completed \>= 180 days prior to registration
- Patients may have received prior radiation therapy; any side effects the patients had due to prior radiation therapy must have resolved to =\< Grade 1 prior to registration; prior radiation therapy must have completed at least 28 days prior to registration
- Patients must have Zubrod performance status of 0-1
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count (ANC) \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Hemoglobin \>= 9 g/dL
- Total bilirubin =\< institutional upper limit of normal (IULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 x IULN
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (178)
Providence Hospital
Mobile, Alabama, 36608, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
University of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
Saint Edward Mercy Medical Center
Fort Smith, Arkansas, 72903, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
University of California Medical Center At Irvine-Orange Campus
Orange, California, 92868, United States
University of California at Davis Cancer Center
Sacramento, California, 95817, United States
Tahoe Forest Cancer Center
Truckee, California, 96161, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Denver Veterans Administration Medical Center
Denver, Colorado, 80220, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, 96817, United States
The Cancer Center of Hawaii-Liliha
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
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Maui Memorial Medical Center
Wailuku, Hawaii, 96793, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
University of Chicago
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
Genesis Medical Center - East Campus
Davenport, Iowa, 52803, United States
Hays Medical Center
Hays, Kansas, 67601, United States
Promise Regional Medical Center-Hutchinson
Hutchinson, Kansas, 65702, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, 66762, United States
Kansas City CCOP
Prairie Village, Kansas, 66208, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, 66606, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Louisiana State University Sciences Center- Monroe
Monroe, Louisiana, 71210, United States
Highland Clinic
Shreveport, Louisiana, 71105, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, 71130, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, 48106, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Oakwood Hospital
Dearborn, Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, 65613, United States
CoxHealth Cancer Center
Branson, Missouri, 65616, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Saint Joseph Health Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, 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
Liberty Hospital
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, 65802, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Saint John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Montana Cancer Consortium CCOP
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, 59102, United States
Billings Clinic
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
University of Rochester
Rochester, New York, 14642, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, 28801, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus CCOP
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Dayton CCOP
Dayton, Ohio, 45420, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis HealthCare System
Zanesville, Ohio, 43701, United States
Adventist Medical Center
Portland, Oregon, 97216, United States
SWOG
Portland, Oregon, 97239, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Upstate Carolina CCOP
Spartanburg, South Carolina, 29303, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, 24115, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, 99336, United States
Evergreen Hospital Medical Center
Kirkland, Washington, 98033, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
Virginia Mason CCOP
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Pacific Medical Center-First Hill
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Group Health Cooperative-Seattle
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
The Polyclinic
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
United General Hospital
Sedro-Woolley, Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Lee SM, Moon J, Redman BG, Chidiac T, Flaherty LE, Zha Y, Othus M, Ribas A, Sondak VK, Gajewski TF, Margolin KA. Phase 2 study of RO4929097, a gamma-secretase inhibitor, in metastatic melanoma: SWOG 0933. Cancer. 2015 Feb 1;121(3):432-440. doi: 10.1002/cncr.29055. Epub 2014 Sep 23.
PMID: 25250858DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melanoma Committee Statistician
- Organization
- SWOG Statistical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Kim Margolin
SWOG Cancer Research Network
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
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2010
First Posted
May 10, 2010
Study Start
October 1, 2010
Primary Completion
May 1, 2013
Study Completion
August 1, 2015
Last Updated
June 14, 2016
Results First Posted
June 14, 2016
Record last verified: 2016-05