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Brief Title: Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery
Official Title: Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer
Study ID: NCT02042443
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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Richard Kim
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR