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Spots Global Cancer Trial Database for Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery

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Study Description

Brief Summary: This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving trametinib is more effective than combination chemotherapy in treating patients with biliary or gallbladder cancer.

Detailed Description: PRIMARY OBJECTIVES: I. To assess overall survival (OS) in patients with refractory advanced biliary cancer randomized to Arm 1: trametinib compared to those randomized to Arm 2: chemotherapy (either 5-fluorouracil \[fluorouracil\] and leucovorin \[leucovorin calcium\] or capecitabine). SECONDARY OBJECTIVES: I. To determine the frequency and severity of adverse events of trametinib in this patient population. II. To assess response rate (RR) and progression-free survival (PFS) in patients randomized to Arm 1: trametinib and patients randomized to Arm 2: chemotherapy (fluorouracil \[5-FU\] or capecitabine in this patient population). TERTIARY OBJECTIVES: I. To determine if a 16-gene expression signature is predictive of mitogen-activated protein kinase kinase (MEK) efficacy as evidenced by improved RR, PFS, and OS. II. To evaluate the effects of trametinib on the inflammatory cytokine and explore potential associations with response rate and survival. III. To estimate lean soft tissue and fat mass weight gain as a result of treatment with trametinib vs. capecitabine in patients with advanced refractory biliary cancer. IV. To bank tissue samples for other future correlative studies including next generation sequencing and whole genome methylation assays. NOTE: These potential future correlative studies will not be performed until an amended protocol with relevant detailed information including specific arms and assays is approved by Cancer Therapy Evaluation Program (CTEP). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive trametinib orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive 1 of 2 treatment regimens at the discretion of the investigator. ARM IIA: Patients receive leucovorin calcium intravenously (IV) over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM IIB: Patients receive capecitabine PO twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States

Alaska Women's Cancer Care, Anchorage, Alaska, United States

Anchorage Oncology Centre, Anchorage, Alaska, United States

Katmai Oncology Group, Anchorage, Alaska, United States

Providence Alaska Medical Center, Anchorage, Alaska, United States

Kaiser Permanente-Anaheim, Anaheim, California, United States

Sutter Auburn Faith Hospital, Auburn, California, United States

Kaiser Permanente-Baldwin Park, Baldwin Park, California, United States

Kaiser Permanente-Bellflower, Bellflower, California, United States

Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States

Mills - Peninsula Hospitals, Burlingame, California, United States

Sutter Davis Hospital, Davis, California, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

Kaiser Permanente Hospital, Fontana, California, United States

Kaiser Permanente - Harbor City, Harbor City, California, United States

Kaiser Permanente-Irvine, Irvine, California, United States

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

Los Angeles County-USC Medical Center, Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

Kaiser Permanente-Cadillac, Los Angeles, California, United States

Fremont - Rideout Cancer Center, Marysville, California, United States

Memorial Medical Center, Modesto, California, United States

Palo Alto Medical Foundation-Camino Division, Mountain View, California, United States

Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, United States

Sutter Cancer Research Consortium, Novato, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

Palo Alto Medical Foundation Health Care, Palo Alto, California, United States

Kaiser Permanente - Panorama City, Panorama City, California, United States

Kaiser Permanente-Riverside, Riverside, California, United States

Sutter Roseville Medical Center, Roseville, California, United States

Sutter General Hospital, Sacramento, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Kaiser Permanente-San Diego Mission, San Diego, California, United States

Kaiser Permanente-San Diego Zion, San Diego, California, United States

California Pacific Medical Center-Pacific Campus, San Francisco, California, United States

Kaiser Permanente-San Marcos, San Marcos, California, United States

Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California, United States

Sutter Pacific Medical Foundation, Santa Rosa, California, United States

Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California, United States

Sutter Solano Medical Center/Cancer Center, Vallejo, California, United States

Kaiser Permanente, Woodland Hills, California, United States

University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States

Memorial Hospital Colorado Springs, Colorado Springs, Colorado, United States

Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, United States

Medical Oncology and Hematology Group PC-Guilford, Guilford, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, United States

Smilow Cancer Hospital-Orange Care Center, Orange, Connecticut, United States

Charlotte Hungerford Hospital Center for Cancer Care, Torrington, Connecticut, United States

Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, United States

University of Florida, Gainesville, Florida, United States

Moffitt Cancer Center, Tampa, Florida, United States

Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States

Kootenai Medical Center, Coeur d'Alene, Idaho, United States

Kootenai Cancer Center, Post Falls, Idaho, United States

Kootenai Cancer Clinic, Sandpoint, Idaho, United States

Saint Joseph Medical Center, Bloomington, Illinois, United States

Illinois CancerCare-Bloomington, Bloomington, Illinois, United States

Illinois CancerCare-Canton, Canton, Illinois, United States

Memorial Hospital of Carbondale, Carbondale, Illinois, United States

Illinois CancerCare-Carthage, Carthage, Illinois, United States

Centralia Oncology Clinic, Centralia, Illinois, United States

Cancer Care Center of Decatur, Decatur, Illinois, United States

Decatur Memorial Hospital, Decatur, Illinois, United States

Crossroads Cancer Center, Effingham, Illinois, United States

Illinois CancerCare-Eureka, Eureka, Illinois, United States

Illinois CancerCare-Galesburg, Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States

Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States

Illinois CancerCare-Macomb, Macomb, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States

Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States

Radiation Oncology of Northern Illinois, Ottawa, Illinois, United States

Illinois CancerCare-Pekin, Pekin, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States

Methodist Medical Center of Illinois, Peoria, Illinois, United States

Illinois CancerCare-Peoria, Peoria, Illinois, United States

OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, United States

OSF Saint Francis Medical Center, Peoria, Illinois, United States

Illinois CancerCare-Peru, Peru, Illinois, United States

Valley Radiation Oncology, Peru, Illinois, United States

Illinois CancerCare-Princeton, Princeton, Illinois, United States

Central Illinois Hematology Oncology Center, Springfield, Illinois, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Springfield Clinic, Springfield, Illinois, United States

Memorial Medical Center, Springfield, Illinois, United States

Reid Health, Richmond, Indiana, United States

Cancer Center of Kansas - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States

Newman Regional Health, Emporia, Kansas, United States

Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States

Saint Catherine Hospital, Garden City, Kansas, United States

Saint Rose Ambulatory and Surgery Center, Great Bend, Kansas, United States

Hays Medical Center, Hays, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

University of Kansas Cancer Center-West, Kansas City, Kansas, United States

University of Kansas Cancer Center, Kansas City, Kansas, United States

Cancer Center of Kansas-Kingman, Kingman, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Cancer Center of Kansas-Liberal, Liberal, Kansas, United States

Cancer Center of Kansas-Manhattan, Manhattan, Kansas, United States

Cancer Center of Kansas - McPherson, McPherson, Kansas, United States

Cancer Center of Kansas - Newton, Newton, Kansas, United States

Olathe Medical Center, Olathe, Kansas, United States

University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States

Cancer Center of Kansas - Parsons, Parsons, Kansas, United States

Via Christi Hospital-Pittsburg, Pittsburg, Kansas, United States

Cancer Center of Kansas - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas - Salina, Salina, Kansas, United States

Salina Regional Health Center, Salina, Kansas, United States

Saint Francis Hospital and Medical Center - Topeka, Topeka, Kansas, United States

Cancer Center of Kansas - Wellington, Wellington, Kansas, United States

Associates In Womens Health, Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas - Wichita, Wichita, Kansas, United States

Via Christi Regional Medical Center, Wichita, Kansas, United States

Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States

Cancer Center of Kansas - Winfield, Winfield, Kansas, United States

Oncology Hematology Care Inc-Crestview, Crestview Hills, Kentucky, United States

Boston Medical Center, Boston, Massachusetts, United States

Lahey Hospital and Medical Center, Burlington, Massachusetts, United States

Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States

Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Bronson Battle Creek, Battle Creek, Michigan, United States

Beaumont Hospital-Dearborn, Dearborn, Michigan, United States

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Saint John Hospital and Medical Center, Detroit, Michigan, United States

Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Mercy Health Saint Mary's, Grand Rapids, Michigan, United States

Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States

Allegiance Health, Jackson, Michigan, United States

Sparrow Hospital, Lansing, Michigan, United States

Saint Mary Mercy Hospital, Livonia, Michigan, United States

Mercy Health Mercy Campus, Muskegon, Michigan, United States

Lakeland Community Hospital, Niles, Michigan, United States

Saint Joseph Mercy Oakland, Pontiac, Michigan, United States

Lake Huron Medical Center, Port Huron, Michigan, United States

Spectrum Health Reed City Hospital, Reed City, Michigan, United States

Saint Mary's of Michigan, Saginaw, Michigan, United States

Lakeland Hospital, Saint Joseph, Michigan, United States

Marie Yeager Cancer Center, Saint Joseph, Michigan, United States

Munson Medical Center, Traverse City, Michigan, United States

Saint John Macomb-Oakland Hospital, Warren, Michigan, United States

Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, United States

Saint Francis Medical Center, Cape Girardeau, Missouri, United States

Southeast Cancer Center, Cape Girardeau, Missouri, United States

Capital Region Medical Center-Goldschmidt Cancer Center, Jefferson City, Missouri, United States

Truman Medical Center, Kansas City, Missouri, United States

The University of Kansas Cancer Center-South, Kansas City, Missouri, United States

The University of Kansas Cancer Center-North, Kansas City, Missouri, United States

The University of Kansas Cancer Center-Lee's Summit, Lee's Summit, Missouri, United States

Phelps County Regional Medical Center, Rolla, Missouri, United States

Saint John's Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States

Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States

Missouri Baptist Medical Center, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States

Cancer Research for the Ozarks NCORP, Springfield, Missouri, United States

Mercy Hospital Springfield, Springfield, Missouri, United States

CoxHealth South Hospital, Springfield, Missouri, United States

Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States

Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills, Missouri, United States

Billings Clinic Cancer Center, Billings, Montana, United States

Montana Cancer Consortium NCORP, Billings, Montana, United States

Saint Vincent Healthcare, Billings, Montana, United States

Bozeman Deaconess Hospital, Bozeman, Montana, United States

Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States

Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States

Saint Peter's Community Hospital, Helena, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States

Community Medical Hospital, Missoula, Montana, United States

Cancer and Blood Specialists-Henderson, Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada - Henderson, Henderson, Nevada, United States

Las Vegas Cancer Center-Henderson, Henderson, Nevada, United States

21st Century Oncology - Henderson, Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson, Nevada, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada, United States

Cancer and Blood Specialists-Shadow, Las Vegas, Nevada, United States

Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, United States

Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, United States

21st Century Oncology, Las Vegas, Nevada, United States

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway, Las Vegas, Nevada, United States

HealthCare Partners Medical Group Oncology/Hematology-San Martin, Las Vegas, Nevada, United States

Radiation Oncology Centers of Nevada Southeast, Las Vegas, Nevada, United States

Cancer Therapy and Integrative Medicine, Las Vegas, Nevada, United States

Cancer and Blood Specialists-Tenaya, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas, Nevada, United States

HealthCare Partners Medical Group Oncology/Hematology-Tenaya, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas, Nevada, United States

Las Vegas Cancer Center-Medical Center, Las Vegas, Nevada, United States

21st Century Oncology - Fort Apache, Las Vegas, Nevada, United States

Cancer and Blood Specialists-Fort Apache, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas, Nevada, United States

21st Century Oncology - Vegas Tenaya, Las Vegas, Nevada, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico, United States

Christus Saint Vincent Regional Cancer Center, Santa Fe, New Mexico, United States

Columbia University/Herbert Irving Cancer Center, New York, New York, United States

University of Rochester, Rochester, New York, United States

Cancer Care of Western North Carolina, Asheville, North Carolina, United States

Mission Hospital-Memorial Campus, Asheville, North Carolina, United States

Asheville Hematology-Oncology Associates, Asheville, North Carolina, United States

Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, United States

Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, United States

Wayne Memorial Hospital, Goldsboro, North Carolina, United States

Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States

Iredell Memorial Hospital, Statesville, North Carolina, United States

Southeastern Medical Oncology Center-Wilson, Wilson, North Carolina, United States

Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina, United States

Strecker Cancer Center-Belpre, Belpre, Ohio, United States

Adena Regional Medical Center, Chillicothe, Ohio, United States

Oncology Hematology Care Inc-Eden Park, Cincinnati, Ohio, United States

Oncology Hematology Care Inc-Mercy West, Cincinnati, Ohio, United States

Oncology Hematology Care Inc - Anderson, Cincinnati, Ohio, United States

Oncology Hematology Care Inc-Kenwood, Cincinnati, Ohio, United States

Oncology Hematology Care Inc-Blue Ash, Cincinnati, Ohio, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

Columbus NCI Community Oncology Research Program, Columbus, Ohio, United States

Grant Medical Center, Columbus, Ohio, United States

The Mark H Zangmeister Center, Columbus, Ohio, United States

Mount Carmel Health Center West, Columbus, Ohio, United States

Doctors Hospital, Columbus, Ohio, United States

Good Samaritan Hospital - Dayton, Dayton, Ohio, United States

Miami Valley Hospital, Dayton, Ohio, United States

Samaritan North Health Center, Dayton, Ohio, United States

Dayton NCI Community Oncology Research Program, Dayton, Ohio, United States

Delaware Health Center-Grady Cancer Center, Delaware, Ohio, United States

Delaware Radiation Oncology, Delaware, Ohio, United States

Grady Memorial Hospital, Delaware, Ohio, United States

Oncology Hematology Care Inc-Healthplex, Fairfield, Ohio, United States

Blanchard Valley Hospital, Findlay, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States

Wayne Hospital, Greenville, Ohio, United States

Kettering Medical Center, Kettering, Ohio, United States

Fairfield Medical Center, Lancaster, Ohio, United States

Marietta Memorial Hospital, Marietta, Ohio, United States

Knox Community Hospital, Mount Vernon, Ohio, United States

Licking Memorial Hospital, Newark, Ohio, United States

Newark Radiation Oncology, Newark, Ohio, United States

Southern Ohio Medical Center, Portsmouth, Ohio, United States

Springfield Regional Medical Center, Springfield, Ohio, United States

Upper Valley Medical Center, Troy, Ohio, United States

Saint Ann's Hospital, Westerville, Ohio, United States

Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Clackamas Radiation Oncology Center, Clackamas, Oregon, United States

Providence Milwaukie Hospital, Milwaukie, Oregon, United States

Providence Newberg Medical Center, Newberg, Oregon, United States

Providence Willamette Falls Medical Center, Oregon City, Oregon, United States

Providence Portland Medical Center, Portland, Oregon, United States

Providence Saint Vincent Medical Center, Portland, Oregon, United States

Oregon Health and Science University, Portland, Oregon, United States

Roper Hospital, Charleston, South Carolina, United States

Charleston Hematology Oncology Associates-Roper, Charleston, South Carolina, United States

Lowcountry Hematology Oncology PA-North Charleston, Charleston, South Carolina, United States

Charleston Hematology Oncology Associates PA-St. Francis, Charleston, South Carolina, United States

Lowcountry Hematology Oncology PA-West Ashley, Charleston, South Carolina, United States

Greenville Health System Cancer Institute-Easley, Easley, South Carolina, United States

Saint Francis Hospital, Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Andrews, Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Butternut, Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States

Greenville Memorial Hospital, Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Greer, Greer, South Carolina, United States

Gibbs Cancer Center-Pelham, Greer, South Carolina, United States

Lowcountry Hematology Oncology PA-Mount Pleasant, Mount Pleasant, South Carolina, United States

Greenville Health System Cancer Institute-Seneca, Seneca, South Carolina, United States

Spartanburg Medical Center, Spartanburg, South Carolina, United States

Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States

Wellmont Bristol Regional Medical Center, Bristol, Tennessee, United States

Wellmont Medical Associates Oncology and Hematology-Johnson City, Johnson City, Tennessee, United States

Wellmont Holston Valley Hospital and Medical Center, Kingsport, Tennessee, United States

Wellmont Medical Associates Oncology and Hematology-Kingsport, Kingsport, Tennessee, United States

The Don and Sybil Harrington Cancer Center, Amarillo, Texas, United States

The Methodist Hospital System, Houston, Texas, United States

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

Southwest VA Regional Cancer Center, Norton, Virginia, United States

PeaceHealth Saint John Medical Center, Longview, Washington, United States

Swedish Medical Center-First Hill, Seattle, Washington, United States

PeaceHealth Southwest Medical Center, Vancouver, Washington, United States

Rocky Mountain Oncology, Casper, Wyoming, United States

Big Horn Basin Cancer Center, Cody, Wyoming, United States

Billings Clinic-Cody, Cody, Wyoming, United States

Welch Cancer Center, Sheridan, Wyoming, United States

Contact Details

Name: Richard Kim

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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