Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
NCT ID: NCT01494506
Last Updated: 2016-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
417 participants
INTERVENTIONAL
2011-11-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MM-398
MM-398 120 mg/m2 Q3W IV. Note: The published dose of ONIVYDE was expressed as the irinotecan hydrochloride trihydrate until October 2015. It is now expressed as the irinotecan free base. Converting a dose based on irinotecan hydrochloride trihydrate to a dose based on irinotecan free base is accomplished by substituting the Molecular Weight of irinotecan hydrochloride trihydrate (677.19 g/mole) with the Molecular Weight of irinotecan free base (586.68 g/mole), which results in a conversion factor of 0.866. 120 mg/m2 dose of irinotecan hydrochloride trihydrate is equivalent to 100 mg/ m2 of irinotecan free base.
MM-398
Arm A: MM-398 120 mg/m2 IV Q3W
Arm C: MM-398 80mg/m2 IV Q2W
5 Fluorouracil and Leucovorin IV
5 Fluorouracil and Leucovorin IV
5 Fluorouracil
Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks
Leucovorin
Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
MM-398, 5-FU and Leucovorin
MM-398 80 mg/m2, 5-FU and Leucovorin Q2W IV. Note: The published dose of ONIVYDE was expressed as the irinotecan hydrochloride trihydrate until October 2015. It is now expressed as the irinotecan free base. Converting a dose based on irinotecan hydrochloride trihydrate to a dose based on irinotecan free base is accomplished by substituting the Molecular Weight of irinotecan hydrochloride trihydrate (677.19 g/mole) with the Molecular Weight of irinotecan free base (586.68 g/mole), which results in a conversion factor of 0.866. 80 mg/m2 dose of irinotecan hydrochloride trihydrate is equivalent to 70 mg/ m2 of irinotecan free base.
MM-398
Arm A: MM-398 120 mg/m2 IV Q3W
Arm C: MM-398 80mg/m2 IV Q2W
5 Fluorouracil
Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks
Leucovorin
Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
Interventions
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MM-398
Arm A: MM-398 120 mg/m2 IV Q3W
Arm C: MM-398 80mg/m2 IV Q2W
5 Fluorouracil
Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks
Leucovorin
Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic disease
* Documented disease progression after prior gemcitabine based therapy
* KPS \>/= 70
* Adequate bone marrow function
* Adequate hepatic function
* Adequate renal function
Exclusion Criteria
* Clinically significant GI disorders
* Severe arterial thromboembolic events less than 6 months before inclusion
* NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
* Active infection or uncontrolled fever
* Pregnant or breast feeding patients
18 Years
ALL
No
Sponsors
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Merrimack Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Eliel Bayever, MD
Role: STUDY_DIRECTOR
Merrimack Pharmaceuticals
Locations
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Gilbert, Arizona, United States
Glendale, Arizona, United States
Scottsdale, Arizona, United States
Burbank, California, United States
Duarte, California, United States
Fresno, California, United States
LaVerne, California, United States
San Luis Obispo, California, United States
Boyton Beach, Florida, United States
Atlanta, Georgia, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Henderson, Nevada, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
Columbus, Ohio, United States
Norman, Oklahoma, United States
Greenville, South Carolina, United States
Bedford, Texas, United States
Dallas, Texas, United States
Tyler, Texas, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Buenos Aires, , Argentina
Rosario, , Argentina
Santa Fe, , Argentina
Westmead, New South Wales, Australia
Kurralta Park, South Australia, Australia
Boxhill, Victoria, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Belo Horizonte, , Brazil
Ijuí, , Brazil
Passo Fundo, , Brazil
Porto Alegre, , Brazil
São Paulo, , Brazil
Montreal, Quebec, Canada
Hořovice, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Příbram, , Czechia
Bordeaux, , France
Lille, , France
Marseille, , France
Berlin, , Germany
Jens, , Germany
Munich, , Germany
Ulm, , Germany
Budapest, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Castellana Grotte, , Italy
Genova, , Italy
Legnano, , Italy
Naples, , Italy
Roma, , Italy
Port Elizabeth, , South Africa
Pretoria, , South Africa
Western Cape, , South Africa
Hwasun-gun, , South Korea
Seoul, , South Korea
Alicante, , Spain
Barcelona, , Spain
Madrid, , Spain
Santander, , Spain
Valencia, , Spain
Chiayi City, , Taiwan
Kaohsiung City, , Taiwan
Taiching, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Sutton, , United Kingdom
Countries
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References
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Chen LT, Macarulla T, Blanc JF, Mirakhur B, de Jong FA, Belanger B, Bekaii-Saab T, Siveke JT. Early dose reduction/delay and the efficacy of liposomal irinotecan with fluorouracil and leucovorin in metastatic pancreatic ductal adenocarcinoma (mPDAC): A post hoc analysis of NAPOLI-1. Pancreatology. 2021 Jan;21(1):192-199. doi: 10.1016/j.pan.2020.10.029. Epub 2020 Oct 10.
Macarulla Mercade T, Chen LT, Li CP, Siveke JT, Cunningham D, Bodoky G, Blanc JF, Lee KH, Dean A, Belanger B, Wang-Gillam A. Liposomal Irinotecan + 5-FU/LV in Metastatic Pancreatic Cancer: Subgroup Analyses of Patient, Tumor, and Previous Treatment Characteristics in the Pivotal NAPOLI-1 Trial. Pancreas. 2020 Jan;49(1):62-75. doi: 10.1097/MPA.0000000000001455.
Bang YJ, Li CP, Lee KH, Chiu CF, Park JO, Shan YS, Kim JS, Chen JS, Shim HJ, Rau KM, Choi HJ, Oh DY, Belanger B, Chen LT. Liposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI-1 study. Cancer Sci. 2020 Feb;111(2):513-527. doi: 10.1111/cas.14264. Epub 2019 Dec 20.
Macarulla T, Blanc JF, Wang-Gillam A, Chen LT, Siveke JT, Mirakhur B, Chen J, de Jong FA. Liposomal irinotecan and 5-fluorouracil/leucovorin in older patients with metastatic pancreatic cancer - A subgroup analysis of the pivotal NAPOLI-1 trial. J Geriatr Oncol. 2019 May;10(3):427-435. doi: 10.1016/j.jgo.2019.02.011. Epub 2019 Mar 4.
Wang-Gillam A, Hubner RA, Siveke JT, Von Hoff DD, Belanger B, de Jong FA, Mirakhur B, Chen LT. NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors. Eur J Cancer. 2019 Feb;108:78-87. doi: 10.1016/j.ejca.2018.12.007. Epub 2019 Jan 14.
Chen LT, Siveke JT, Wang-Gillam A, Li CP, Bodoky G, Dean AP, Shan YS, Jameson GS, Macarulla T, Lee KH, Cunningham D, Blanc JF, Chiu CF, Schwartsmann G, Braiteh FS, Mamlouk K, Belanger B, de Jong FA, Hubner RA. Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a global phase 3 trial. Eur J Cancer. 2018 Dec;105:71-78. doi: 10.1016/j.ejca.2018.09.010. Epub 2018 Nov 8.
Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.
Other Identifiers
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MM-398-07-03-01
Identifier Type: -
Identifier Source: org_study_id
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