History of Changes for Study: NCT00794417
`
`A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced
`Carcinoma
`
`Latest version (submitted November 13, 2020) on ClinicalTrials.gov
`
`A study version is represented by a row in the table.
`
`Select two study versions to compare. One each from columns A and B.
`
`Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only
`applies to the Protocol section of the study.
`
`Click "Compare" to do the comparison and show the differences.
`
`Select a version's Submitted Date link to see a rendering of the study for that version.
`
`The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
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`Hover over the "Recruitment Status" to see how the study's recruitment status changed.
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`Study edits or deletions are displayed in red .
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`Study additions are displayed in green .
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`Study Record Versions
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`Version
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`A
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`B
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`Submitted Date
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`Changes
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`1
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`2
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`November 19, 2008 None (earliest Version on record)
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`May 27, 2009 Study Status
`
`Exhibit 2053
`Page 01 of 09
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`
`
`A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced
`Carcinoma
`
`Latest version (submitted November 13, 2020) on ClinicalTrials.gov
`
`A study version is represented by a row in the table.
`
`Select two study versions to compare. One each from columns A and B.
`
`Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only
`applies to the Protocol section of the study.
`
`Click "Compare" to do the comparison and show the differences.
`
`Select a version's Submitted Date link to see a rendering of the study for that version.
`
`The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
`
`Hover over the "Recruitment Status" to see how the study's recruitment status changed.
`
`Study edits or deletions are displayed in red .
`
`Study additions are displayed in green .
`
`Study Record Versions
`
`Version
`
`A
`
`B
`
`Submitted Date
`
`Changes
`
`1
`
`2
`
`November 19, 2008 None (earliest Version on record)
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`May 27, 2009 Study Status
`
`Exhibit 2053
`Page 01 of 09
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`Version
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`A
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`B
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`Submitted Date
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`Changes
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`3
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`4
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`5
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`6
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`7
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`8
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`9
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`10
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`11
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`12
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`13
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`14
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`November 25, 2009 Study Status, Contacts/Locations, Conditions and Sponsor/Collaborators
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`January 6, 2010 Contacts/Locations and Study Status
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`July 19, 2010 Contacts/Locations and Study Status
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`January 5, 2011 Study Status
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`January 21, 2011 Recruitment Status, Study Status and Contacts/Locations
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`February 11, 2011 Study Status
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`February 16, 2011 Study Design and Study Status
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`April 17, 2011 Study Status
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`May 27, 2011 Arms and Interventions and Study Status
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`January 6, 2012 Recruitment Status, Study Status, Sponsor/Collaborators and Contacts/Locations
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`August 30, 2012 Study Status
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`Results Submission Events
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`November 13, 2020 Recruitment Status, Study Status, Outcome Measures, Arms and Interventions, More Information, Study
`Design, Study Description, Adverse Events, Baseline Characteristics, Participant Flow, References, Eligibility
`and Study Identification
`
`Compare
`
` Comparison Format:
`
` Merged
` Side-by-Side
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`Scroll up to access the controls
`
`Exhibit 2053
`Page 02 of 09
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`Study NCT00794417
`Submitted Date: November 19, 2008 (v1)
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` Study Identification
`
`Unique Protocol ID: VGFT-ST-0708
`
`Brief Title: A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With
`Advanced Carcinoma
`
`Official Title: A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients
`With Advanced Carcinoma
`
`Secondary IDs: TCD10767
`
` Study Status
`
`Record Verification: November 2008
`
`Overall Status: Recruiting
`
`Study Start: September 2008
`
`Primary Completion: September 2010 [Anticipated]
`
`Study Completion: October 2010 [Anticipated]
`
`First Submitted: November 19, 2008
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`First Submitted that
`Met QC Criteria:
`
`November 19, 2008
`
`First Posted: November 20, 2008 [Estimate]
`
`Last Update Submitted that
`Met QC Criteria:
`
`November 19, 2008
`
`Last Update Posted: November 20, 2008 [Estimate]
`
`Exhibit 2053
`Page 03 of 09
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`
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` Sponsor/Collaborators
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`Sponsor: Regeneron Pharmaceuticals
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`Responsible Party:
`
`Collaborators: Sanofi
`
` Oversight
`
`U.S. FDA-regulated Drug:
`
`U.S. FDA-regulated Device:
`
`Data Monitoring: No
`
` Study Description
`
`Brief Summary: The purpose of the study is to determine whether the combination of aflibercept, pemetrexed and cisplatin
`is safe and effective.
`
`Detailed Description: The study will be conducted in two phases. In phase 1, patients with advanced cancer will receive different
`doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of
`phase 1 is to determine the safest dose of the combined study medications. This dose will then be
`administered to patients with previously untreated non-small cell lung cancer in phase 2. The phase 2
`portion of the study will determine if the combination is effective in treating non-small cell lung cancer.
`
`Exhibit 2053
`Page 04 of 09
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` Conditions
`
`Conditions: Advanced Carcinoma
`Non-Small Cell Lung Cancer
`
`Keywords: advanced cancer
`lung cancer
`NSCLC
`Non-small Cell Lung Cancer
`aflibercept
`chemotherapy
`
` Study Design
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`Study Type: Interventional
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`Primary Purpose: Treatment
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`Study Phase: Phase 1/Phase 2
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`Interventional Study Model: Single Group Assignment
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`Number of Arms: 1
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`Masking: None (Open Label)
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`Allocation: N/A
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`Enrollment: 100 [Anticipated]
`
`Exhibit 2053
`Page 05 of 09
`
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` Arms and Interventions
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`Experimental: 1
`
`Arms
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`Assigned Interventions
`Drug: Combination of aflibercept, pemetrexed and
`cisplatin
`Aflibercept in combination with pemetrexed and
`cisplatin administered via intravenous infusion.
`Other Names:
`Alimta
`
` Outcome Measures
`
`Primary Outcome Measures:
`
`1. Phase 1: Dose limiting toxicities; Phase 2: Objective Response Rate (ORR) and Progression Free
`Survival (PFS)
`[ Time Frame: 6 months ]
`
`
`Secondary Outcome Measures:
`
`1. Safety, pharmacokinetic and immunogenic profile of aflibercept when given in combination with
`pemetrexed and cisplatin
`[ Time Frame: 12 months ]
`
`
` Eligibility
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`Minimum Age: 18 Years
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`Maximum Age:
`
`Sex: All
`
`Exhibit 2053
`Page 06 of 09
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`
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`Gender Based:
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`Accepts Healthy Volunteers: No
`
`Criteria: Inclusion Criteria:
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`Confirmation of cancer by biopsy (tissue sample)
`Phase 1: patients with advanced or metastatic disease that have failed conventional therapy
`Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and
`cavitating lesions
`Age ≥18 years
`ECOG performance status 0-1
`Adequate renal, liver and bone marrow function.
`Negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the
`initial dose of aflibercept
`Ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
`Institutional Review Board (IRB) approved, signed and dated informed consent form
`
`Exclusion Criteria:
`
`Prior treatment with study medications
`Untreated, symptomatic, or progressive Central Nervous System cancer and/or spinal cord
`compression. Patients with treated brain metastases must have been without symptoms for at least
`3 months
`Surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound
`healing
`Anti-VEGF therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
`Chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
`Other investigational treatment up to 4 weeks prior to the initial administration of aflibercept
`Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept:
`Severe cardiovascular disease or event
`Cerebrovascular accident, transient ischemic attack, or moderate to severe peripheral
`neuropathy
`Erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis
`
`Exhibit 2053
`Page 07 of 09
`
`
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`Deep vein thrombosis, pulmonary embolism, or other clotting event
`Episode(s)of moderate to severe, continuous bleeding
`Breast-feeding or pregnancy
`
` Contacts/Locations
`
`Study Officials: MD
`Study Director
`Regeneron Pharmaceuticals
`Locations: United States, California
`Stanford University Medical Center
`[Recruiting]
`Stanford, California, United States, 94305
`Contact:
`Contact: Melanie San Pedro-Salcedo 650-724-1388 msanpedro@stanford.edu
`Contact:
`Principal Investigator: Heather Wakelee, MD
`Canada, Ontario
`Princess Margaret Hospital
`[Recruiting]
`Toronto, Ontario, Canada
`Contact:
`Contact: Lillian Siu, MD 416-946-2911 Lillian.siu@uhn.on.ca
`Contact:
`Principal Investigator: Lillian Siu, MD
`
` IPDSharing
`
`Plan to Share IPD:
`
`Exhibit 2053
`Page 08 of 09
`
`
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` References
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`Citations:
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`Links:
`
`Available IPD/Information:
`
`Scroll up to access the controls
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`Scroll to the Study top
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`U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
`
`Exhibit 2053
`Page 09 of 09
`
`
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