[sheet: Schedule 1 - Participating Site]
Site Number | Institution Name | Street Address | City | State | ZIP Code | Principal Investigator | PI Credentials | PI Title | IRB of Record | IRB Registration Number | Lead Site Designation | Planned Enrollment Allocation | Site Activation Target Date | Notes
001 | Graystone University Medical Center | 1200 University Avenue | Philadelphia | PA | 19104 | Dr. Catherine Aldridge, M.D., Ph.D. | M.D., Ph.D. | Professor of Oncology; Global Principal Investigator | Graystone University Institutional Review Board | IRB00012847 | Yes | 80 | 2023-07-15 | Lead site; Global PI site; individual IRB approval required
002 | Lakemont Medical Center | 4400 North Michigan Drive | Chicago | IL | 60611 | Dr. Howard Matsuoka, M.D. | M.D. | Assoc. Professor of Hepatology & Oncology; Co-Principal Investigator | Veridian Central IRB | N/A | Yes | 65 | 2023-07-18 | Lead site; Co-PI site; individual IRB approval required
003 | Haverford Regional Medical Center | 85 Commonwealth Avenue | Boston | MA | 02115 | Dr. Renata Voss, M.D. | M.D. | Associate Professor of Medical Oncology | Veridian Central IRB | N/A | No | 38 | 2023-08-01
004 | Cedar Falls University Hospital | 2200 Colfax Boulevard | Denver | CO | 80218 | Dr. James Whitcomb, M.D., Ph.D. | M.D., Ph.D. | Professor of Gastrointestinal Oncology | Veridian Central IRB | N/A | No | 35 | 2023-08-05
005 | Weston Memorial Health System | 600 Peachtree Center Avenue | Atlanta | GA | 30308 | Dr. Lydia Chen-Barros, M.D. | M.D. | Director of Hepatobiliary Oncology Program | Veridian Central IRB | N/A | No | 38 | 2023-08-01
006 | Ridgeview Academic Medical Center | 310 Medical Center Drive | Houston | TX | 77030 | Dr. Tariq Halabi, M.D. | M.D. | Associate Professor of Medical Oncology | Veridian Central IRB | N/A | No | 40 | 2023-08-10
007 | Brookhaven University Hospital | 450 Longwood Avenue | Baltimore | MD | 21287 | Dr. Samantha Riordan, M.D. | M.D. | Assistant Professor of Oncology | Veridian Central IRB | N/A | No | 32 | 2023-08-12
008 | Clearwater Regional Medical Center | 1100 NW 14th Street | Miami | FL | 33136 | Dr. Eduardo Reyes, M.D. | M.D. | Professor of Hepatology | Veridian Central IRB | N/A | No | 35 | 2023-08-08
009 | Northfield University Health System | 525 East 68th Street | New York | NY | 10065 | Dr. Angela Park, M.D., Ph.D. | M.D., Ph.D. | Associate Professor of GI Oncology | Veridian Central IRB | N/A | No | 38 | 2023-08-05
010 | Hawthorne Medical Center | 3400 Spruce Street | Philadelphia | PA | 19104 | Dr. Martin Guillory, M.D. | M.D. | Associate Professor of Surgical Oncology | Graystone University Institutional Review Board | IRB00012847 | No | 30 | 2023-08-15 | Pennsylvania site; uses Graystone IRB
011 | Summitview Community Hospital | 750 West Harrison Street | Chicago | IL | 60612 | Dr. Patricia Ng, M.D. | M.D. | Clinical Associate, Medical Oncology | Veridian Central IRB | N/A | No | 28 | 2023-08-18
012 | Pinehurst University Medical Center | 3181 SW Sam Jackson Park Road | Portland | OR | 97239 | Dr. Kevin Lindstrom, M.D. | M.D. | Professor of Liver Oncology | Veridian Central IRB | N/A | No | 30 | 2023-08-20
013 | Briarwood Cancer Research Institute | 200 Hawkins Drive | Iowa City | IA | 52242 | Dr. Rachel Okonkwo, M.D. | M.D. | Associate Professor of Medical Oncology | Veridian Central IRB | N/A | No | 25 | 2023-08-22
014 | Bayshore Cancer Center | 505 Parnassus Avenue | San Francisco | CA | 94143 | Dr. Michelle Tanaka, M.D. | M.D. | Professor of Hepatobiliary Oncology | Veridian Central IRB | N/A | No | 35 | 2023-08-25
015 | Crescent Valley Medical Center | 8700 Beverly Boulevard | Los Angeles | CA | 90048 | Dr. Jonathan Everett, M.D. | M.D. | Associate Professor of GI Oncology | Veridian Central IRB | N/A | No | 30 | 2023-08-28
016 | Eastlake University Hospital | 11100 Euclid Avenue | Cleveland | OH | 44106 | Dr. Diane Kowalski, M.D. | M.D. | Associate Professor of Medical Oncology | Veridian Central IRB | N/A | No | 28 | 2023-08-22
017 | Piedmont Regional Cancer Center | 1120 South Tryon Street | Charlotte | NC | 28203 | Dr. William Frasier, M.D. | M.D. | Director of Oncology Research | Veridian Central IRB | N/A | No | 28 | 2023-08-25
018 | Kensington University Hospital | 3500 Market Street | Philadelphia | PA | 19104 | Dr. Nadia Petrova, M.D. | M.D. | Assistant Professor of Oncology | Graystone University Institutional Review Board | IRB00012847 | No | 25 | 2023-09-01 | Pennsylvania site; uses Graystone IRB
019 | Maplewood Health Sciences Center | 1 Brookline Place | Brookline | MA | 02445 | Dr. Gregory Thornton, M.D. | M.D. | Associate Professor of Hepatology | Veridian Central IRB | N/A | No | 32 | 2023-08-28
020 | Fort Worth Oncology Associates | 900 Eighth Avenue | Fort Worth | TX | 76104 | Dr. Sandra Huerta, M.D. | M.D. | Clinical Professor of GI Oncology | Veridian Central IRB | N/A | No | 40 | 2023-08-30
021 | Riverside Clinical Research Center | 1301 Morris Park Avenue | Bronx | NY | 10461 | Dr. Thomas Brennan, M.D. | M.D. | Associate Professor of Oncology | Veridian Central IRB | N/A | No | 30 | 2023-09-01
022 | Oceanview Medical Center | 4150 Clement Street | San Diego | CA | 92161 | Dr. Lauren Fujimoto, M.D. | M.D. | Assistant Professor of Liver Oncology | Veridian Central IRB | N/A | No | 25 | 2023-09-05
023 | Lakewood General Hospital | 9500 Gilman Drive | Tampa | FL | 33612 | Dr. Carlos Mendoza, M.D. | M.D. | Professor of Medical Oncology | Veridian Central IRB | N/A | No | 30 | 2023-09-01
024 | Sterling Heights University Hospital | 462 First Avenue | New York | NY | 10016 | Dr. Rebecca Sternberg, M.D., Ph.D. | M.D., Ph.D. | Professor of Translational Oncology | Veridian Central IRB | N/A | No | 28 | 2023-09-05
025 | Valley Forge Cancer Institute | 1025 Walnut Street | Philadelphia | PA | 19107 | Dr. Steven Blackwell, M.D. | M.D. | Associate Professor of Oncology | Graystone University Institutional Review Board | IRB00012847 | No | 22 | 2023-09-08 | Pennsylvania site; uses Graystone IRB
026 | Willowbrook Regional Medical Center | 2160 South First Avenue | Maywood | IL | 60153 | Dr. Christine Alaimo, M.D. | M.D. | Assistant Professor of Hepatology | Veridian Central IRB | N/A | No | 18 | 2023-09-10
027 | Highland Park Research Hospital | 3333 Burnet Avenue | Cincinnati | OH | 45229 | Dr. Andrew Novak, M.D. | M.D. | Associate Professor of GI Oncology | Veridian Central IRB | N/A | No | 27 | 2023-09-08
028 | Grandview Medical Research Center | 4500 San Pablo Road | Jacksonville | FL | 32224 | Dr. Maria Costello, M.D. | M.D. | Director of Clinical Trials, Oncology | Veridian Central IRB | N/A | No | 30 | 2023-09-10
029 | Ashford University Medical Center | 101 Manning Drive | Chapel Hill | NC | 27514 | Dr. Daniel Hargrove, M.D., Ph.D. | M.D., Ph.D. | Professor of Hepatobiliary Surgery & Oncology | Veridian Central IRB | N/A | No | 27 | 2023-09-12
030 | Westfield Community Medical Center | 300 Pasteur Drive | Aurora | CO | 80045 | Dr. Lisa Carmichael, M.D. | M.D. | Assistant Professor of Medical Oncology | Veridian Central IRB | N/A | No | 25 | 2023-09-15
031 | Silverbrook Oncology Center | 530 East 70th Street | New York | NY | 10021 | Dr. Philip Castellano, M.D. | M.D. | Clinical Professor of GI Medical Oncology | Veridian Central IRB | N/A | No | 24 | 2023-09-12
032 | Greenfield Clinical Research Hospital | 1515 Holcombe Boulevard | Houston | TX | 77030 | Dr. Priya Bhattacharya, M.D. | M.D. | Associate Professor of Hepatology & Oncology | Veridian Central IRB | N/A | No | 40 | 2023-09-15
033 | Crestwood University Hospital | 55 Lake Avenue North | Worcester | MA | 01655 | Dr. Alan Richardson, M.D. | M.D. | Associate Professor of Medical Oncology | Veridian Central IRB | N/A | No | 30 | 2023-09-18
034 | Cedarbrook Medical Center | 5200 Centre Avenue | Pittsburgh | PA | 15232 | Dr. Margaret Sullivan, M.D. | M.D. | Professor of Medical Oncology | Graystone University Institutional Review Board | IRB00012847 | No | 18 | 2023-09-20 | Pennsylvania site; uses Graystone IRB
035 | Thorndale Regional Health System | 3200 SW Veterans Hospital Road | Portland | OR | 97239 | Dr. Scott Yamamoto, M.D. | M.D. | Assistant Professor of Liver Oncology | Veridian Central IRB | N/A | No | 25 | 2023-09-18
036 | Fairview Community Hospital | 2901 South Capital of Texas Highway | Atlanta | GA | 30322 | Dr. Vanessa Oduya, M.D. | M.D. | Associate Professor of Medical Oncology | Veridian Central IRB | N/A | No | 27 | 2023-09-20
037 | Meridian Heights Medical Center | 4801 Linton Boulevard | Delray Beach | MD | 21201 | Dr. Robert Kinsley, M.D. | M.D. | Director of GI Oncology Research | Veridian Central IRB | N/A | No | 28 | 2023-09-22
038 | Springdale Research Institute | 1200 South Cedar Crest Boulevard | Naperville | IL | 60540 | Dr. Karen Delacroix, M.D. | M.D. | Assistant Professor of Oncology | Veridian Central IRB | N/A | No | 14 | 2023-09-25
TOTAL | 1200 | 38 sites across 14 states
[sheet: Summary by State]
State | State Name | Number of Sites | Total Planned Enrollment | IRB(s) of Record
CA | California | 3 | 90 | Veridian Central IRB
CO | Colorado | 2 | 60 | Veridian Central IRB
FL | Florida | 3 | 95 | Veridian Central IRB
GA | Georgia | 2 | 65 | Veridian Central IRB
IA | Iowa | 1 | 25 | Veridian Central IRB
IL | Illinois | 4 | 125 | Veridian Central IRB
MA | Massachusetts | 3 | 100 | Veridian Central IRB
MD | Maryland | 2 | 60 | Veridian Central IRB
NC | North Carolina | 2 | 55 | Veridian Central IRB
NY | New York | 4 | 120 | Veridian Central IRB
OH | Ohio | 2 | 55 | Veridian Central IRB
OR | Oregon | 2 | 55 | Veridian Central IRB
PA | Pennsylvania | 5 | 175 | Graystone University Institutional Review Board (IRB00012847)
TX | Texas | 3 | 120 | Veridian Central IRB
TOTAL | 38 | 1200
[sheet: Schedule Notes]
Field | Value / Description
Schedule Title | Schedule 1 — List of Participating Veridian Network Sites
Agreement Reference | Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc., dated June 28, 2023
Protocol Number | PPC-4871-III
Protocol Short Title | CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology
Investigational Product | Penterafenib (PPC-4871)
Indication | Advanced hepatocellular carcinoma (HCC), second-line after prior systemic therapy
ClinicalTrials.gov Identifier | NCT05928174
IND Number | IND 157823
Sponsor | Penterra Pharmaceuticals Corp., 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540
Site Network | Veridian Health Research Network, Inc., 750 Research Parkway, 8th Floor, Philadelphia, PA 19104
Veridian EIN | 23-4178205
Total Sites | 38
Number of States | 14
Total Planned Enrollment | 1,200 subjects (800 treatment : 400 placebo; 2:1 randomization)
Enrollment Period | 42 months from first patient in (target FPI: August 14, 2023)
Total Study Duration | 60 months (42-month enrollment + 18-month follow-up)
Projected Last Patient In | February 2027
Projected Study Completion | August 2028
Lead Site 1 | Graystone University Medical Center (Site 001), Philadelphia, PA — Global PI: Dr. Catherine Aldridge, M.D., Ph.D.
Lead Site 2 | Lakemont Medical Center (Site 002), Chicago, IL — Co-PI: Dr. Howard Matsuoka, M.D.
IRB — Pennsylvania Sites | Graystone University Institutional Review Board (IRB Registration: IRB00012847)
IRB — Non-Pennsylvania Sites | Veridian Central IRB (under IRB Authorization Agreement per 2018 revised Common Rule)
Per-Patient Site Fee | $52,000 per subject (milestone-based: 4 × $13,000)
Start-Up Fee per Site | $75,000 (50% at activation, 50% at first patient enrolled)
Annual Site Maintenance Fee | $40,000 per site per year
CRO | Meridian Contract Research Organization, Inc., 9200 Corporate Boulevard, Raleigh, NC 27615
EDC Vendor | Pinnacle Data Solutions, Inc., 6000 Clearwater Drive, San Diego, CA 92121
Central Laboratory | Northbridge Bioanalytical Laboratories, Inc., 2900 Commerce Way, Baltimore, MD 21224
Sponsor Insurance Carrier | Briarcliff Mutual Insurance Company, Policy No. BM-CTL-2023-04182
Effective Date of MCTA | July 18, 2023
Note | Enrollment allocations are targets and may be adjusted by Sponsor in consultation with Veridian based on actual enrollment rates, subject to Protocol amendment if total enrollment changes.