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Study Protocol Protocol 05 I4T-MC-JVCZ Randomized Phase 2 Trial Evaluating Alternative Ramucirumab Doses in Combination with Paclitaxel in Second-Line Metastatic or Locally Advanced, Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma NCT02514551 Approval Date: 07-May-2015 I4T-MC-JVCZ Clinical Protocol Page 1 Protocol I4T-MC-JVCZ Randomized Phase 2 Trial Evaluating Alternative Ramucirumab Doses in Combination with Paclitaxel in Second-Line Metastatic or Locally Advanced, Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma Confidential Information The information contained in this protocol is confidential and is intended for the use of clinical investigators. It is the property of Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical investigation of ramucirumab (LY3009806), unless such persons are bound by a confidentiality agreement with Eli Lilly and Company or its subsidiaries. This document and its associated attachments are subject to United States Freedom of Information Act Exemption 4. Ramucirumab (LY3009806) An open-label, randomized Phase 2 study comparing alternative ramucirumab dose in combination with paclitaxel in approximately 240 patients with metastatic or locally advanced gastric or gastroesophageal junction adenocarcinoma with disease progression during or following prior combination chemotherapy. Treatment will continue until a discontinuation criterion is met. Eli Lilly and Company Indianapolis, Indiana USA 46285 Protocol Electronically Signed and Approved by Lilly on date provided below. Approval Date: 07-May-2015 GMT LY3009806 I4T-MC-JVCZ Clinical Protocol Page 2 Table of Contents Randomized Phase 2 Trial Evaluating Alternative Ramucirumab Doses in Combination with Paclitaxel in Second-Line Metastatic or Locally Advanced, Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma Section Page 1. Synopsis .............................................................................................................................9 2. Introduction ......................................................................................................................12 3. Objectives and Endpoints..................................................................................................13 4. Study Design.....................................................................................................................14 4.1. Overview of Study Design ...........................................................................................14 4.2. Rationale for Study Design...........................................................................................17 4.3. Benefit/Risk Assessment ..............................................................................................18 4.4. Study Completion and End of Trial ..............................................................................19 5. Study Population...............................................................................................................20 5.1. Inclusion Criteria..........................................................................................................20 5.2. Exclusion Criteria ........................................................................................................22 5.2.1. Re-Screening........................................................................................................24 6. Treatment..........................................................................................................................25 6.1. Treatments Administered .............................................................................................25 6.1.1. Selection and Timing of Doses.............................................................................25 6.1.1.1. Premedication.................................................................................................26 6.1.1.1.1. Premedication Prior to Administration of Ramucirumab ...........................................................................................26 6.1.1.1.2. Premedication Prior to Administration of Paclitaxel..................................26 6.1.1.2. Administration of Ramucirumab.....................................................................26 6.1.1.3. Administration of Paclitaxel ...........................................................................27 6.1.2. Investigator Responsibilities.................................................................................28 6.2. Treatment Assignment .................................................................................................29 6.3. Blinding .......................................................................................................................29 6.4. Packaging and Labeling ...............................................................................................29 6.5. Preparation/Handling/Storage.......................................................................................29 6.6. Dose Modification........................................................................................................29 6.6.1. Ramucirumab Dose Modifications .......................................................................29 6.6.1.1. Ramucirumab Dose Modifications for AESIs .................................................30 6.6.1.2. Ramucirumab Dose Modifications for Non-AESIs .........................................32 LY3009806 I4T-MC-JVCZ Clinical Protocol Page 3 6.6.2. Paclitaxel Dose Modifications ..............................................................................33 6.7. Treatment Compliance .................................................................................................33 6.8. Concomitant Therapy...................................................................................................33 6.9. Treatment After Study Completion (Continued Access Period) ....................................34 7. Discontinuation Criteria ....................................................................................................35 7.1. Discontinuation From Study Treatment ........................................................................35 7.1.1. Discontinuation of Inadvertently Enrolled Patients...............................................36 7.2. Discontinuation from the Study....................................................................................37 7.2.1. Patients Who Are Lost to Follow-Up....................................................................37 8. Study Assessments and Procedures ...................................................................................38 8.1. Efficacy........................................................................................................................38 8.1.1. Efficacy Assessments at Baseline and During Study Treatment.............................................................................................................38 8.1.2. Efficacy Assessments During Postdiscontinuation Follow- Up........................................................................................................................38 8.1.3. Efficacy Measures................................................................................................39 8.1.4. Appropriateness of Measurements........................................................................39 8.2. Safety...........................................................................................................................39 8.2.1. Adverse Events ....................................................................................................40 8.2.1.1. Adverse Events of Special Interest for Ramucirumab......................................42 8.2.1.1.1. Infusion-Related Reactions .......................................................................42 8.2.1.1.1.1. Guidelines for Reporting IRRs ............................................................42 8.2.1.1.2. Hypertension ............................................................................................42 8.2.1.1.3. Proteinuria ................................................................................................43 8.2.1.1.4. Thromboembolic Events ...........................................................................43 8.2.1.1.4.1. Arterial Thromboembolic Events ........................................................43 8.2.1.1.4.2. Venous Thromboembolic Events.........................................................43 8.2.1.1.5. Bleeding/Hemorrhage ...............................................................................43 8.2.1.1.6. Gastrointestinal Perforation.......................................................................43 8.2.1.1.7. Reversible Posterior Leukoencephalopathy Syndrome ..............................44 8.2.1.1.8. Congestive Heart Failure ..........................................................................44 8.2.1.1.9. Fistula Formation......................................................................................44 8.2.1.1.10. Surgery and Impaired Wound Healing ......................................................45 8.2.1.1.11. Liver Failure and Other Significant Liver Injury .......................................45 8.2.1.2. Serious Adverse Events ..................................................................................45 8.2.1.3. Suspected Unexpected Serious Adverse Reactions..........................................46
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