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Study Protocol Clovis Oncology, Inc. Clinical Protocol Oral rucaparib (CO-338) CO-338-010 29 June 2016 A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients with gBRCA Mutation Ovarian Cancer or Other Solid Tumor Protocol Number: CO-338-010 Investigational Product: Oral rucaparib (CO-338) Eudra CT Number: IND Number: Development Phase: Phase I/II Indication Studied: Locally advanced or metastatic solid tumors, including lymphoma, and germline BRCA (gBRCA) ovarian cancer Sponsor Name and Address: Clovis Oncology, Inc. 5500 Flatiron Parkway, Suite 100 Boulder, CO 80301 U.S.A. Responsible Medical Officer: Compliance Statement: This study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, clinical research guidelines established by the Code of Federal Regulations (Title 21, CFR Parts 50, 56, and 312), and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. Essential study documents will be archived in accordance with applicable regulations. CONFIDENTIALITY STATEMENT The information in this document contains commercial information and trade secrets that are privileged or confidential and may not be disclosed unless such disclosure is required by applicable laws and regulations. In any event, persons to whom the information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as privileged or confidential. Page 1 of 133 Confidential Clovis Oncology, Inc. Clinical Protocol Oral rucaparib (CO-338) CO-338-010 29 June 2016 Protocol Acceptance Form Protocol: CO-338-010 Title: A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients with gBRCA Mutation Ovarian Cancer, or Other Solid Tumor Date: 29 June 2016 I have carefully read this protocol and agree that it contains all of the necessary information required to conduct this study. I agree to conduct this study as described and according to the Declaration of Helsinki, ICH Guidelines for GCP, and all applicable regulatory requirements. Investigator’s Signature Date Name (printed) Page 3 of 133 Confidential Clovis Oncology, Inc. Clinical Protocol Oral rucaparib (CO-338) CO-338-010 29 June 2016 Table of Contents Description Page 1 SYNOPSIS ......................................................................................................................... 12 2 LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ............................... 27 3 INTRODUCTION............................................................................................................. 30 3.1 DNA Repair and Cancer Therapy ................................................................................. 30 3.2 Background ................................................................................................................... 30 3.2.1 Nonclinical Experience ........................................................................................... 31 3.2.1.1 Rucaparib Absorption, Distribution, Metabolism, and Excretion ............... 31 3.2.1.2 Multiple-Dose Toxicity Studies .................................................................. 32 3.2.1.3 Additional Observations .............................................................................. 33 3.2.2 Clinical Experience ................................................................................................. 34 3.2.2.1 Rucaparib Monotherapy .............................................................................. 34 3.2.2.2 Recommended Phase II Dose (RP2D) of Rucaparib Monotherapy ............ 37 3.2.2.3 Absorption, Distribution, Metabolism, and Elimination ............................. 37 3.3 Rationale for Study ....................................................................................................... 38 4 STUDY OBJECTIVES ..................................................................................................... 40 4.1 Objectives and Endpoints ............................................................................................. 40 5 STUDY DESIGN ............................................................................................................... 42 5.1 Overall Study Design and Plan ..................................................................................... 42 5.1.1 Screening Period ..................................................................................................... 42 5.1.2 Part 1 (Phase I Portion) ........................................................................................... 42 5.1.3 Part 2 (Phase II Portion in Patients with BRCA-Mutant Ovarian Cancer) .................................................................................................................... 44 5.1.4 Part 3 (Phase II PK Portion in Patients with any Advanced Solid Tumor) .................................................................................................................... 44 5.1.5 End-of-Treatment and Follow-Up (Part 1, Part 2, and Part 3) ................................ 45 5.1.6 End of Study ........................................................................................................... 45 5.2 Study Schema................................................................................................................ 45 6 STUDY POPULATION ................................................................................................... 49 6.1 Number of Patients and Sites ........................................................................................ 49 6.2 Inclusion Criteria .......................................................................................................... 49 Page 4 of 133 Confidential Clovis Oncology, Inc. Clinical Protocol Oral rucaparib (CO-338) CO-338-010 29 June 2016 6.3 Exclusion Criteria ......................................................................................................... 52 6.4 Patients or Partners of Patients of Reproductive Potential ........................................... 53 6.5 Waivers of Inclusion/Exclusion Criteria ....................................................................... 54 7 DESCRIPTION OF STUDY TREATMENTS AND DOSE MODIFICATIONS ........................................................................................................... 55 7.1 Description of Investigational Product ......................................................................... 55 7.2 Method of Assigning Patients to Treatment Groups..................................................... 55 7.3 Preparation and Administration of Protocol-Specified Treatment ............................... 55 7.3.1 Dietary Restrictions ................................................................................................ 56 7.3.2 Fed and Fasted Requirements for Food-Effect PK Analysis .................................. 56 7.4 Starting Dose and Dose Modifications of Protocol-Specified Treatment .................... 57 7.4.1 Part 1 (Phase I Portion) ........................................................................................... 57 7.4.1.1 Dose Escalation ........................................................................................... 57 7.4.1.2 Maximum Tolerated Dose ........................................................................... 59 7.4.1.3 Dose-Escalation Design .............................................................................. 59 7.4.1.4 Dose-Limiting Toxicity ............................................................................... 61 7.4.1.5 Definition of DLT-Evaluable Patient .......................................................... 61 7.4.1.6 In the Event of Toxicity at Lowest Dose Level .......................................... 61 7.4.1.7 Recommended Phase II Dose ...................................................................... 61 7.4.1.8 Dose Modification Criteria ......................................................................... 62 7.4.1.8.1 Management of Rucaparib Treatment-emergent ALT/AST Elevations ....................................................................................... 62 7.4.1.9 Intrapatient Dose Escalation ....................................................................... 63 7.4.1.10 Criteria for Re-Treatment ............................................................................ 64 7.4.2 Part 2 and Part 3 (Phase II Portion) ........................................................................ 64 7.4.2.1 Starting Dose ............................................................................................... 64 7.4.2.2 Dose Modification Criteria ......................................................................... 64 7.4.3 In the Event of Torsade de Pointes ......................................................................... 65 7.4.4 Treatment Beyond Progression ............................................................................... 65 7.5 Accountability of Protocol-Specified Treatment .......................................................... 66 7.6 Blinding/Masking of Treatment .................................................................................... 66 7.7 Treatment Compliance .................................................................................................
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