Colorectal Cancer Clinical Trial
Official title:
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen
| Verified date | March 2019 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.
| Status | Terminated |
| Enrollment | 266 |
| Est. completion date | February 2015 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Metastatic colorectal carcinoma with KRAS mutation - Received first line therapy and discontinued part or all of first line therapy - Estimated life expectancy > 3 months - Stage IV disease - Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 - Adequate hepatic and hematologic function - No major operations within 4 weeks prior to treatment start Exclusion Criteria: - More than 1 prior chemotherapy regimen for Stage 4 colorectal cancer - Experimental medical treatment within 30 days prior to study entry - Known or suspected cerebral metastases - History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment - Known dihydropyrimidine dehydrogenase-deficiency (special screening not required) - Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or electrocardiogram (ECG) abnormalities consistent with ischemia - Uncontrolled hypertension (seated systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) at screening - Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis - Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization - Prior irinotecan therapy for metastatic disease is not permitted - Systemic fungal, bacterial, viral, or other infection Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Universitaire Estaing | Clermont Ferrand | Auvergne |
| France | Centre Georges François Leclerc | Dijon | |
| France | Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique | Lille Cedex | |
| France | Centre Hospitalier Régional Universitaire Hôpital Saint Eloi | Montpellier Cedex 5 | |
| France | Centre Antoine Lacassagne | Nice Cedex 2 | |
| France | Centre Eugène Marquis | Rennes Cedex | Bretagne |
| France | Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer | Rennes Cedex | |
| France | Hôpital Trousseau - Service de Gastroenterologie | Tours | |
| Germany | Medizinische Universitätsklinik Bochum | Bochum | Nordrhein-Westfalen |
| Germany | Universitätsklinikum Dresden | Dresden | Sachsen |
| Germany | Universitätsklinikum Essen | Essen | Nordrhein-Westfalen |
| Germany | Städtisches Klinikum Frankfurt-Höchst | Frankfurt | |
| Germany | Katholisches Marienkrankenhaus gGmbH | Hamburg | |
| Germany | Klinikum Region Hannover GmbH, Krankenhaus Siloah | Hannover | Niedersachsen |
| Germany | Universitätsklinikum der Friedrich-Schiller-Universität Jena | Jena | Thuringen |
| Germany | University Magdeburg | Magdeburg | |
| Germany | Universitätsklinikums Mannheim | Mannheim | Baden-Wuerttenberg |
| Germany | Ludwig-Maximilians-Universität München Klinikum Großhadern | München | Bayern |
| Germany | Universitätsklinikum Rostock | Rostock | Mecklenburg-Vorpommern |
| Germany | Krankenanstalt Mutterhaus der Borromäerinnen e.V. | Trier | Rheinland-Pfalz |
| Germany | Universitätsklinikum Ulm | Ulm | Baden-Wuerttemberg |
| Italy | Ospedale Unico Versilia | Lido di Camaiore | Lucca |
| Italy | Istituto Europeo di Oncologia | Milano | |
| Italy | Ospedale Niguarda Cà Granda | Milano | |
| Italy | Azienda Ospedaliera San Gerardo di Monza | Monza | Monza E Brianza |
| Italy | Arcispedale Santa Maria Nuova IRCCS | Reggio Emilia | Reggio Nella Emilia |
| Italy | Ospedale Civile SS Annunziata ASL 1 | Sassari | |
| Poland | Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy | Bydgoszcz | |
| Poland | Uniwersyteckie Centrum Kliniczne | Gdansk | Pomorskie |
| Poland | Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o. | Kraków | Malopolskie |
| Poland | Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o. | Olsztyn | Warminsko-Mazurskie |
| Poland | Centralny Szpital Kliniczny MSWiA | Warszawa | |
| Poland | Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie | Warszawa | |
| Russian Federation | State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary" | Arkhangelsk | |
| Russian Federation | Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan | Kazan | |
| Russian Federation | Kursk Regional Oncologic Dispensary | Kursk | |
| Russian Federation | Cancer Research Center n.a. Blokhin, Chemotherapy Dept. | Moscow | |
| Russian Federation | Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD" | Moscow | |
| Russian Federation | State Institution "Blokhin Cancer Research Centre RAMS" | Moscow | |
| Russian Federation | Nizhny Novgorod City Oncology Dispensary | Nizhny Novgorod | |
| Russian Federation | State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary" | Omsk | |
| Russian Federation | N.N.Petrov Research Institute of Oncology | Saint Petersburg | |
| Spain | Centro Oncológico Regional de Galicia | A Coruña | La Coruna |
| Spain | Hospital Nuestra Señora de Sonsoles | Avila | |
| Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
| Spain | Hospital Universitario de Girona Doctor Josep Trueta | Gerona | |
| Spain | Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro | Madrid | |
| Spain | Hospital Clinico Universitario San Carlos | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal | Madrid | |
| Spain | Instituto de Investigación Sanitaria | Madrid | |
| Spain | Hospital Clinico Universitario de Valencia | Valencia | |
| United States | Central Hematology Oncology Medical Group, Inc. | Alhambra | California |
| United States | Peachtree Hematology Oncology Consultants, PC | Atlanta | Georgia |
| United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Providence Saint Joseph Medical Center-Disney Family Cancer Center | Burbank | California |
| United States | Northwestern University | Chicago | Illinois |
| United States | Oncology Hematology Care, Inc. | Cincinnati | Ohio |
| United States | South Carolina Oncology Associates | Columbia | South Carolina |
| United States | Wilshire Oncology Medical Group, Inc. | Corona | California |
| United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | Virginal Cancer Specialists, PC | Fairfax | Virginia |
| United States | Center for Cancer and Blood Disorders, PC | Fort Worth | Texas |
| United States | Saint Jude Heritage Healthcare | Fullerton | California |
| United States | Florida Cancer Specialists | Gainesville | Florida |
| United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
| United States | Comprehensive Cancer Centers of Nevada | Henderson | Nevada |
| United States | Clearview Cancer Institute | Huntsville | Alabama |
| United States | Indiana University Simon Cancer Center | Indianapolis | Indiana |
| United States | West Michigan Cancer Center | Kalamazoo | Michigan |
| United States | University of California San Diego Medical Center | La Jolla | California |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | Suburban Hematology Oncology Associates, PC | Lawrenceville | Georgia |
| United States | Southeast Nebraska Cancer Center | Lincoln | Nebraska |
| United States | Pacific Shores Medical Group | Long Beach | California |
| United States | Comprehensive Hematology Oncology Centers, Inc. | Los Angeles | California |
| United States | TORI Network (Translational Oncology Research Intl) | Los Angeles | California |
| United States | UCLA Community Oncology Practice | Los Angeles | California |
| United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
| United States | University of Wisconsin | Madison | Wisconsin |
| United States | Signal Point Clinical Research Center, LLC | Middletown | Ohio |
| United States | Virginia Cancer Institute | Midlothian | Virginia |
| United States | Montana Cancer Institute | Missoula | Montana |
| United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
| United States | Yale University Smilow Cancer Hospital | New Haven | Connecticut |
| United States | New York University Clinical Cancer Center | New York | New York |
| United States | MD Anderson Cancer Center | Orlando | Florida |
| United States | Stanford University Medical Center | Palo Alto | California |
| United States | Wilshire Oncology Medical Group, Inc. | Pomona | California |
| United States | Kaiser Permanente Northwest Region Oncology Hematology | Portland | Oregon |
| United States | Cancer Care Associates Medical Group | Redondo Beach | California |
| United States | Pacific Shores Medical Group | Redondo Beach | California |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | Intermountain Healthcare | Saint George | Utah |
| United States | Saint Joseph Oncology, Inc. | Saint Joseph | Missouri |
| United States | Florida Cancer Specialists | Saint Petersburg | Florida |
| United States | Utah Cancer Specialists | Salt Lake City | Utah |
| United States | Sharp Health Care | San Diego | California |
| United States | San Jose Medical Group | San Jose | California |
| United States | Central Coast Medical Oncology Corp | Santa Maria | California |
| United States | Seattle Cancer Care Alliance | Seattle | Washington |
| United States | Scott & White Memorial | Temple | Texas |
| United States | Hematology and Oncology Associates at BridgePoint | Tupelo | Mississippi |
| United States | Georgetown University | Washington | District of Columbia |
| United States | The Center for Cancer and Blood Disorders | Weatherford | Texas |
| United States | Oncology Hematology Care, Inc. | Wilmington | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, France, Germany, Italy, Poland, Russian Federation, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates. | Randomization up to 27 months | |
| Secondary | Overall Survival (OS) | The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates. | Randomization up to 33 months | |
| Secondary | Objective Response Rate (ORR) | Objective response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The ORR was defined as the percentage of participants who achieved a CR or PR. | Randomization up to 27 months |
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