History of Changes for Study: NCT00644124
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`Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-Cell Lymphoma
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`Latest version (submitted May 5, 2016) on ClinicalTrials.gov
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`A study version is represented by a row in the table.
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`Select two study versions to compare. One each from columns A and B.
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`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.
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`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.
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`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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`2
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`3
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`March 21, 2008 None (earliest Version on record)
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`April 25, 2008 Study Status
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`June 2, 2008 Study Status
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`Exhibit 2079
`Page 01 of 08
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`Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-Cell Lymphoma
`
`Latest version (submitted May 5, 2016) 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
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`Changes
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`1
`
`2
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`3
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`March 21, 2008 None (earliest Version on record)
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`April 25, 2008 Study Status
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`June 2, 2008 Study Status
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`Exhibit 2079
`Page 01 of 08
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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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`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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`September 19, 2008 Study Status, Outcome Measures and Study Identification
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`March 3, 2009 Study Status
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`March 10, 2009 Recruitment Status, Contacts/Locations and Study Status
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`August 30, 2011 Sponsor/Collaborators, Study Status, Study Identification and References
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`January 3, 2012 Recruitment Status, Study Status and Study Design
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`May 5, 2016 Arms and Interventions, Study Status, Study Design and Study Identification
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`Compare
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` Comparison Format:
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` Merged
` Side-by-Side
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`Scroll up to access the controls
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`Study NCT00644124
`Submitted Date: March 21, 2008 (v1)
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` Study Identification
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`Unique Protocol ID: TCD10173
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`Brief Title: Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-Cell Lymphoma
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`Official Title: A Phase I Open-Label Dose-Escalation Study of Intravenous Aflibercept (AVE0005, VEGF Trap) in
`Combination With R-CHOP Administered Every 2 Weeks or Every 3 Weeks in Patients With Non
`Hodgkin's B-Cell Lymphoma
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`Secondary IDs: AVE0005
`EudraCT 2007-003737-16
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`Exhibit 2079
`Page 02 of 08
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` Study Status
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`Record Verification: March 2008
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`Overall Status: Recruiting
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`Study Start: March 2008
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`Primary Completion:
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`Study Completion:
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`First Submitted: March 21, 2008
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`First Submitted that
`Met QC Criteria:
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`March 21, 2008
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`First Posted: March 26, 2008 [Estimate]
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`Last Update Submitted that
`Met QC Criteria:
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`March 21, 2008
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`Last Update Posted: March 26, 2008 [Estimate]
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` Sponsor/Collaborators
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`Sponsor: Sanofi
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`Responsible Party:
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`Collaborators: Regeneron Pharmaceuticals
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`Exhibit 2079
`Page 03 of 08
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` Oversight
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`U.S. FDA-regulated Drug:
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`U.S. FDA-regulated Device:
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`Data Monitoring: No
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` Study Description
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`Brief Summary: The purpose of this study is to determine the selected dose of aflibercept when it is combined with R-
`CHOP treatment (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal
`Methotrexate) administered every 2 weeks or every 3 weeks, in non Hodgkin B-cell lymphoma, and to
`determine how the body handles aflibercept when it is administered with R-CHOP.
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`Detailed Description:
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` Conditions
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`Conditions: Lymphoma, Non-Hodgkin
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`Keywords: Non-Hodgkin's lymphoma
`angiogenesis inhibitors
`CHOP protocol
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`Exhibit 2079
`Page 04 of 08
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` Study Design
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`Study Type: Interventional
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`Primary Purpose: Treatment
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`Study Phase: Phase 1
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`Interventional Study Model: Parallel Assignment
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`Number of Arms:
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`Masking: None (Open Label)
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`Allocation: Non-Randomized
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`Enrollment: 50 [Anticipated]
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` Arms and Interventions
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`Intervention Details:
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`Drug: aflibercept
`in combination with standard treatment R-CHOP
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`Exhibit 2079
`Page 05 of 08
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` Outcome Measures
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`Primary Outcome Measures:
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`1. selected dose of aflibercept based on Dose Limiting Toxicities observed
`[ Time Frame: cycle 1 +/- 2 ]
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`Secondary Outcome Measures:
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`1. Adverse events
`[ Time Frame: treatment period ]
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`2. Response rate
`[ Time Frame: cycle 2, 4 and 8 ]
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`3. Progression free survival
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`4. Biomarkers
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` Eligibility
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`Minimum Age: 18 Years
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`Maximum Age:
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`Sex: All
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`Gender Based:
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`Accepts Healthy Volunteers: No
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`Exhibit 2079
`Page 06 of 08
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`Criteria: Inclusion Criteria:
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`Patients with non-Hodgkin B-cell lymphoma, good condition, not previously treated
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`Exclusion Criteria:
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`Contraindication to any drug contained in the R-CHOP
`(Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate)
`Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of
`inclusion
`Cerebral or leptomeningeal involvement.
`History of another neoplasm (Adequately treated basal cell or squamous cell skin cancers,
`carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for
`> 5 years are allowed)
`Participation in another clinical trial and any concurrent treatment with any investigational drug within
`30 days prior to the first drug intake
`Any acute or chronic medical condition, which could impair the ability of the patient to participate to
`the study or could interfere with interpretation of study results
`Uncontrolled diabetes mellitus
`Uncontrolled hypertension
`Abnormal kidney function
`Evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy
`Pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an
`effective method of contraception
`History of hypersensitivity to any Trap agents or recombinant proteins
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`Exhibit 2079
`Page 07 of 08
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` Contacts/Locations
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`Central Contact Person: Public Registry ICD
`Email: GV-Contact-us@sanofi-aventis.com
`Study Officials: Corinne Haioun, MD
`Principal Investigator
`Groupe d'Etudes du Lymphome de l'Adulte
`Locations: France
`Sanofi-Aventis Administrative Office
`[Recruiting]
`Paris, France
`Contact:
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`Contact: GV-Contact-us@sanofi-aventis.com
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` IPDSharing
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`Plan to Share IPD:
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` References
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`Citations:
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`Links: URL: http://www.sanofi-aventis.com
`Description: Related Info
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`
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`Available IPD/Information:
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`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
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`Exhibit 2079
`Page 08 of 08
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