Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer (Sequoia)

Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Biological: Pegilodecakin; Drug: FOLFOX

Detailed Description

This is an open-label, multi-center, randomized, Phase 3 study designed to compare the efficacy and safety of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic adenocarcinoma of the pancreas who have progressed on one prior gemcitabine containing regimen.

• Study Type: Interventional
• Enrollment (Actual): 567
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • St Vincent's Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Warringal Private Hospital
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital Malvern
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • St John of God Murdoch Hospital
• Austria
  • Salzburg, Austria, 5020
    • Universitätsklinikum Salzburg
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4010
      • KH der Barmherzigen Schwestern Linz BetriebsGesmbH
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Universitätsklinikum Graz
• Belgium
  • Bonheiden, Belgium, 2820
    • Imeldaziekenhuis
  • Brussel, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • Brussel, Belgium, 1070
    • Hospital Universitaire Erasme Brussel
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi-Site Notre-Dame
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • Namur, Belgium, 5000
    • Clinique St Elisabeth Namur
  • Yvoir, Belgium, 5530
    • CHU Dinant Godinne - UCL Namur
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Regional Cancer Center
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • McGill University
• France
  • Besancon Cedex, France, 25030
    • CHU de Besancon Hopital Jean Minjoz
  • Paris CEDEX 13, France, 75651
    • Hopital de la Pitie Salpetriere
  • Poitiers, France, 86021
    • CHU La Miletrie
  • Trevenans, France, 90400
    • Hôpital Nord Franche-Comté
• Germany
  • Berlin, Germany, 13353
    • Charité Universitätsmedizin Berlin
  • Bochum, Germany
    • St Josef-Hospital Bochum
  • Freiburg, Germany
    • Universitätsklinikum Freiburg
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Bayern
    • München, Bayern, Germany, 81737
      • Städtisches Klinikum München
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • Kliniken Essen-Mitte Ev. Huyssens-Stiftung
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitätsklinikum Carl Gustav Carus
• Italy
  • Ancona, Italy, 60100
    • Ospedale le Torrette
  • Genova, Italy, 16132
    • Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
  • Milano, Italy, 20132
    • IRCCS Ospedale San Raffaele
  • Milano, Italy, 20162
    • Ospedale Niguarda Cà Granda
  • Naples, Italy
    • AOU dell'Università degli Studi della Campania Luigi Vanvitelli
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto
  • Pavia, Italy, 27100
    • Policlinico San Matteo
  • Reggio Emilia, Italy, 42123
    • Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia
  • Roma, Italy, 00155
    • Università Campus Biomedico
  • Forli
    • Meldola, Forli, Italy, 47014
      • Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
  • Torino
    • Candiolo, Torino, Italy
      • Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Busan Gwang'yeogsi
    • Busan, Busan Gwang'yeogsi, Korea, Republic of, 49201
      • Dong-A University Medical Center
  • Jeonnam
    • Hwasun-gun, Jeonnam, Korea, Republic of, 519-809
      • Chonnam National University Hwasun Hospital
  • Korea
    • Seoul, Korea, Korea, Republic of, 06351
      • Samsung Medical Center
    • Seoul, Korea, Korea, Republic of, 06591
      • Seoul St. Mary's Hospital
    • Seoul, Korea, Korea, Republic of, 03722
      • Severance Hospital Yonsei University Health System
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne
  • Poznan, Poland, 60-569
    • Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg
  • Rzeszow, Poland, 35-025
    • Centrum Medyczne Medyk
  • Torun, Poland, 87-100
    • Wojewodzki Szpital Zespolony
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario Alicante
  • Barcelona, Spain, 08025
    • Hospital de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Hospital Universitario Germans Trias i Pujol
  • Burgos, Spain, 9005
    • Hospital General Yagüe
  • Córdoba, Spain, 14001
    • C.H. Regional Reina Sofia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28050
    • Hospital Madrid Norte Sanchinarro
  • Malaga, Spain, 29011
    • Regional University Hospital in Malaga
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen Del Rocio
  • Barcelona
    • Hospitaled DE Llobre, Barcelona, Spain, 08907
      • Hospital Duran I Reynals
  • La Coruna
    • Santiago de Compostela, La Coruna, Spain, 15706
      • Hospital Clinico Universitario de Santiago
• Taiwan
  • Neihu Taipei, Taiwan, 11490
    • Tri-Service General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Addenbrookes Hospital
  • London
    • Acton, London, United Kingdom, W12 0HS
      • Hammersmith Hospital
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF14 2TL
      • Velindre Hospital
  • Surrey
    • London, Surrey, United Kingdom, SE1 9RT
      • Guys/St. Thomas Hospital
    • London, Surrey, United Kingdom, NW1 2BU
      • University College London Hospital Foundation Trust
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center
    • Goodyear, Arizona, United States, 85338
      • Cancer Treatment Centers of America
    • Phoenix, Arizona, United States, 85004
      • University of Arizona Cancer Center
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood And Cancer Center
    • Fullerton, California, United States, 92935
      • St. Joseph Heritage Healthcare
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
    • Los Angeles, California, United States, 90033
      • USC Norris Cancer Hospital
    • Los Angeles, California, United States, 90095
      • TRIO - Translational Research in Oncology-US, Inc.
    • Redondo Beach, California, United States, 90277
      • Cancer Care Associates Medical Group
    • Santa Maria, California, United States, 93454
      • Central Coast Medical Oncology Corporation
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Lynn Cancer Institute Ctr for Hem-Onc
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital/Joe Dimaggio Childrens Hospital
    • Jacksonville, Florida, United States, 32207
      • Baptist Cancer Institute
    • Lakeland, Florida, United States, 33805
      • Watson Clinic
    • Orlando, Florida, United States, 32804
      • Florida Hospital Cancer Institute
    • Orlando, Florida, United States, 32806
      • UF Health Cancer Center- Orlando Health
  • Georgia
    • Athens, Georgia, United States, 30607
      • Northeast Georgia Cancer Care, LLC
    • Newnan, Georgia, United States, 30265
      • Southeastern Regional Medical Center
  • Idaho
    • Caldwell, Idaho, United States, 83605
      • Saint Alphonsus Regional Medical Center
  • Illinois
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46815
      • Fort Wayne Oncology & Hematology
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Medical Center
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Hematology Oncology Clinic
  • Maine
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists - Scarborough
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Virginia Piper Cancer Institute
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • St Louis Cancer Care
  • New Jersey
    • Summit, New Jersey, United States, 07902
      • Summit Medical Group
  • New York
    • East Setauket, New York, United States, 11733
      • North Shore Hematology Oncology Associates
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health, Oncology Research Institute
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73190
      • University of Oklahoma Health Sciences Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
    • Philadelphia, Pennsylvania, United States, 19124
      • Eastern Regional Medical Center
    • Pittsburgh, Pennsylvania, United States, 15232-1305
      • UPMC Hillman Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology PLLC
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute SCRI
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Oncology-Austin Midtown
    • Plano, Texas, United States, 75075
      • Texas Oncology-Plano East
    • San Antonio, Texas, United States, 78240
      • Texas Oncology - San Antonio Medical Center
    • The Woodlands, Texas, United States, 77380
      • US Oncology
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Tyler
    • Tyler, Texas, United States, 75701
      • HOPE Cancer Center of East Texas
    • Wichita Falls, Texas, United States, 76310
      • Texas Oncology-Wichital Falls Texoma Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah School of Medicine
  • Virginia
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute
  • Washington
    • Spokane, Washington, United States, 99208
      • Medical Oncology Associates, PS
    • Tacoma, Washington, United States, 98002
      • MultiCare Regional Cancer Center - Auburn
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54308
      • Aurora West Allis Medical Center
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The presence of metastatic pancreatic adenocarcinoma
2. Measurable disease per RECIST v.1.1
3. Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
4. Eastern Cooperative Oncology Group Performance Status of 0 - 1
5. Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
6. Participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
7. Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
8. No peripheral neuropathy
9. No known history of dihydropyrimidine dehydrogenase deficiency

Exclusion Criteria:

1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
2. Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
3. Participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen
4. Participants who were intolerant of a gemcitabine containing regimen.
5. History of positivity for human immunodeficiency virus
6. Chronic active or active viral hepatitis A, B, or C infection
7. Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
8. Pregnant or lactating women
9. Participants with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
10. Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks
11. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
12. Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pegilodecakin + FOLFOX; Pegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.	Biological: Pegilodecakin; Pegilodecakin plus FOLFOX; Other Names: LY3500518; AM0010; Drug: FOLFOX; FOLFOX Alone; Other Names: 5-FU; oxaliplatin; leucovorin
Active Comparator: FOLFOX; FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.	Drug: FOLFOX; FOLFOX Alone; Other Names: 5-FU; oxaliplatin; leucovorin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.	Randomization to date of death from any cause (Up To 30 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.	Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator	ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response.	Randomization to PD (Up To 30 Months)
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)	Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.	Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)
Duration of Response (DOR)	DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.	Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)
Percentage of Participants Alive at 1 Year (12-Month Survival Rate)	The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.	From randomization to until the date of first documented date of death from any cause within 12 months

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: ARMO BioSciences

Publications and helpful links

General Publications

• Hecht JR, Lonardi S, Bendell J, Sim HW, Macarulla T, Lopez CD, Van Cutsem E, Munoz Martin AJ, Park JO, Greil R, Wang H, Hozak RR, Gueorguieva I, Lin Y, Rao S, Ryoo BY. Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA). J Clin Oncol. 2021 Apr 1;39(10):1108-1118. doi: 10.1200/JCO.20.02232. Epub 2021 Feb 8.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): September 9, 2019
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: April 15, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Oxaliplatin; Leucovorin
• Other Study ID Numbers: 17158; J1L-AM-JZGB (Other Identifier: Eli Lilly and Company); AM0010-301 (Other Identifier: ARMO BioSciences); 2016-003858-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No