History of Changes for Study: NCT01148615
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`A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors
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`Latest version (submitted January 12, 2012) 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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`B
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`Submitted Date
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`June 21, 2010 None (earliest Version on record)
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`June 22, 2010 Sponsor/Collaborators and Study Status
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`July 8, 2010 Recruitment Status, Study Status and Contacts/Locations
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`Exhibit 2054
`Page 01 of 08
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`A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors
`
`Latest version (submitted January 12, 2012) 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
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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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`June 21, 2010 None (earliest Version on record)
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`June 22, 2010 Sponsor/Collaborators and Study Status
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`July 8, 2010 Recruitment Status, Study Status and Contacts/Locations
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`Exhibit 2054
`Page 01 of 08
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`Submitted Date
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`August 24, 2010 Contacts/Locations and Study Status
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`September 10, 2010 Study Status and Study Identification
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`March 14, 2011 Contacts/Locations, Study Status and Sponsor/Collaborators
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`October 3, 2011 Study Status and Sponsor/Collaborators
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`January 12, 2012 Recruitment Status, Study Status, Contacts/Locations and Study Design
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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 NCT01148615
`Submitted Date: June 21, 2010 (v1)
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` Study Identification
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`Unique Protocol ID: TCD11382
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`Brief Title: A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors
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`Official Title: A Phase I, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous
`Aflibercept in Combination With Intravenous Docetaxel Administrated Every 3 Weeks in Chinese Patients
`With Advanced Solid Malignancies
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`Secondary IDs:
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`Exhibit 2054
`Page 02 of 08
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` Study Status
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`Record Verification: June 2010
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`Overall Status: Not yet recruiting
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`Study Start: July 2010
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`Primary Completion: July 2011 [Anticipated]
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`Study Completion: January 2012 [Anticipated]
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`First Submitted: June 21, 2010
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`June 21, 2010
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`First Submitted that
`Met QC Criteria:
`First Posted: June 22, 2010 [Estimate]
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`Last Update Submitted that
`Met QC Criteria:
`Last Update Posted: June 22, 2010 [Estimate]
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`June 21, 2010
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` Sponsor/Collaborators
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`Sponsor: Sanofi
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`Responsible Party:
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`Collaborators:
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`Exhibit 2054
`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: Primary Objective:
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`To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of
`intravenous (IV) aflibercept when administered in combination with docetaxel given intravenously
`every 3 weeks in Chinese patients with solid tumors.
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`Secondary Objectives:
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`To assess the safety profile of intravenous (IV) aflibercept when administered in combination with
`docetaxel
`To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in
`combination
`To make a preliminary assessment of antitumor effects of the combination of docetaxel plus
`aflibercept in patients with evaluable disease
`To evaluate the immunogenicity of IV aflibercept
`To measure endogenous free Vascular Endothelial Growth Factor (VEGF)
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`Detailed Description: The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after
`the last aflibercept administration. Patients will be administered aflibercept in combination with docetaxel
`until when/if a definitive treatment discontinuation criterion is met such as progressive disease,
`unacceptable toxicity or patient refusal to continue.
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`Exhibit 2054
`Page 04 of 08
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` Conditions
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` Study Design
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`Conditions: Neoplasm Malignant
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`Keywords:
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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: 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: 22 [Anticipated]
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` Arms and Interventions
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`Arms
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`Experimental: Aflibercept/ docetaxel
`Patients with advanced cancer will receive different doses of aflibercept in
`combination with approved dose of docetaxel.
`Aflibercept 4 or 6mg/kg over 1 hour IV immediately followed by Docetaxel
`75mg/m2 IV over 1 hour on Day 1, every 3 weeks
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`Assigned Interventions
`Drug: Aflibercept (AVE0005)
`Pharmaceutical form: solution for infusion
`Route of administration: intravenous
`Drug: Docetaxel (XRP6976)
`Pharmaceutical form: solution for infusion
`Route of administration: intravenous
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`Exhibit 2054
`Page 05 of 08
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` Outcome Measures
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`Primary Outcome Measures:
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`1. Dose-Limiting Toxicity (DLT)
`[ Time Frame: 3 weeks (cycle 1) ]
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`Secondary Outcome Measures:
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`1. Global safety profile based on treatment emergent adverse events, serious adverse events, and
`laboratory abnormalities
`[ Time Frame: Up to 30 days after last administration within a maximum follow up of 18 months ]
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`2. Pharmacokinetic parameters of aflibercept
`[ Time Frame: up to last aflibercept administration +90 days ]
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`3. Pharmacokinetic parameters of docetaxel
`[ Time Frame: cycle 1 ]
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`4. Tumor response rate as calculated by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
`[ Time Frame: up to a maximum follow-up of 18 months ]
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`5. Immunogenicity of Aflibercept
`[ Time Frame: up to last aflibercept administration+90 days ]
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`6. Endogenous free VEGF
`[ Time Frame: up to last aflibercept administration+30 days ]
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`Exhibit 2054
`Page 06 of 08
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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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`Criteria: Inclusion criteria :
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`Histologically or cytologically confirmed solid malignancy that metastatic or unresectable for which
`standard curative measures do not exist, but for which docetaxel treatment is appropriate.
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`Exclusion criteria :
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`Squamous histology/cytology lung cancer
`Need for a major surgical procedure or radiation therapy during the study
`Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent
`within 28 days
`Cumulative radiation therapy to >25% of the total bone marrow
`History of brain metastases
`Eastern Cooperative Oncology Group(ECOG)>1
`Prior docetaxel treatment but have not been appropriate for safety reasons
`Inadequate organ and bone marrow function
`Uncontrolled hypertension
`Evidence of clinically significant bleeding diathesis or underlying coagulopathy
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`The above information is not intended to contain all considerations relevant to a patient's potential
`participation in a clinical trial.
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`Exhibit 2054
`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: International Clinical Development Study Director
`Study Director
`Sanofi
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`Locations:
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` IPDSharing
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`Plan to Share IPD:
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` References
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`Links:
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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 2054
`Page 08 of 08
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