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S1513 Revision #2 (Contd.) Page 2 S1513 Revision #2 (contd.) Page 2 The above-referenced protocol and consent has been revised as follows. 1. Title page: Version date has been updated. 2. Section 3.1.c: • Added New Risk: • Rare But Serious: Leukemia secondary to oncology chemotherapy • Increase in Risk Attribution • Changed to Rare But Serious from Also Reported on ABT-888 Trials But With Insufficient Evidence for Attribution: Myelodysplastic syndrome; Treatment related secondary malignancy • Provided Further Clarification: • Blood and lymphatic system disorders - Other (bone marrow failure) is now reported as Bone marrow hypocellular. • Infections and infestations - Other (shingles) (CTCAE 4.0 language) is now reported as Shingles. • Injury, poisoning and procedural complications - Other (radiation proctitis) (CTCAE 4.0 language) is now reported as Radiation recall reaction (dermatologic). • Musculoskeletal and connective tissue disorder - Other (muscle spasms) (CTCAE 4.0 language) is now reported as Muscle cramp. • Renal and urinary disorders - Other (dysuria) (CTCAE 4.0 language) is now reported as Dysuria. • Skin and subcutaneous tissue disorders - Other (nail bed changes) (CTCAE 4.0 language) is now reported as Nail changes. 3. ICD: • Added: • Rare: Cancer of bone marrow caused by chemotherapy; A new cancer resulting from treatment of earlier cancer; Damage to the bone marrow (irreversible) which may cause infection, bleeding, may require transfusions. This memorandum serves to notify the NCI and the SWOG Statistics and Data Management Center. cc: PROTOCOL & INFORMATION OFFICE – Merck Merck Merck S1513 Page 1 Version Date 6/6/18 PRIVILEGED COMMUNICATION Activated September 1, 2016 FOR INVESTIGATIONAL USE ONLY SWOG RANDOMIZED PHASE II STUDY OF 2ND LINE FOLFIRI VERSUS MODIFIED FOLFIRI WITH PARP INHIBITOR ABT-888 (VELIPARIB) (NSC-737664) IN METASTATIC PANCREATIC CANCER NCT#02890355 STUDY CHAIRS: AGENTS: Elena Gabriela Chiorean, M.D. IND-Exempt Agents: (Medical Oncology) Fluorouracil (5-FU, Adrucil ®) (NSC-19893) University of Washington Irinotecan (Camptosar ®) (NSC-616348) 825 Eastlake Ave E, G4830 Leucovorin (NSC-3590) Seattle, WA 98109 Phone: 206/288-6248 FAX: 206/288-2042 NCI Supplied Investigational Agents (DCTD sponsored): E-mail: [email protected] ABT-888 (Veliparib) (NSC-737664) (IND-129716) , M.D., Ph.D., BIOSTATISTICIANS: Karmanos Cancer Center (Medical Oncology) Wayne State University , M.S. 4100 John R Street 4HWCRC , Ph.D. Detroit MI 48201 SWOG Statistical Center Fred Hutchinson Cancer Research Center 1100 Fairview Avenue N, M3-C102 P.O. Box 19024 Seattle, WA 98109-1024 , M.D. (Translational University of Washington Medicine) Box 356460 1959 NE Pacific Street Seattle, WA 98195 ALLIANCE STUDY CHAIRS: M.D., Ph.D. Lombardi Comprehensive Cancer Center , M.D. (Pathology) Georgetown University University of Washington 3800 Reservoir Rd NW Box 359791 Washington DC 20007 325 Ninth Avenue Seattle, WA 98104 ECOG STUDY CHAIRS: , MD Ingram Professor of Cancer Research S1513 Page 2 Version Date 6/6/18 PARTICIPANTS ALLIANCE/Alliance for Clinical Trials in Oncology ECOG-ACRIN/ECOG-ACRIN Cancer Research Group NRG/NRG Oncology SWOG/SWOG S1513 Page 3 Version Date 6/6/18 TABLE OF CONTENTS TITLE ......................................................................................................................................................... 1 PARTICIPANTS ............................................................................................................................................ 2 TABLE OF CONTENTS ............................................................................................................................... 3 CANCER TRIALS SUPPORT UNIT (CTSU) ADDRESS AND CONTACT INFORMATION ....................... 5 SCHEMA ....................................................................................................................................................... 6 1.0 OBJECTIVES .................................................................................................................................. 7 1.1 Primary Objective ............................................................................................................................. 7 1.2 Secondary Objectives ...................................................................................................................... 7 1.3 Translational Objectives ................................................................................................................... 7 2.0 BACKGROUND ............................................................................................................................... 7 3.0 DRUG INFORMATION .................................................................................................................. 14 3.1 ABT-888 (Veliparib) (NSC-737664) (IND-129716) ........................................................................ 14 3.2 Fluorouracil (5-FU, Adrucil®) (NSC-19893) ................................................................................... 20 3.3 Irinotecan (Camptosar®) (NSC-616348) ....................................................................................... 22 3.4 Leucovorin (NSC-3590) ................................................................................................................. 23 4.0 STAGING CRITERIA ..................................................................................................................... 24 5.0 ELIGIBILITY CRITERIA ................................................................................................................ 24 5.1 Disease Related Criteria ................................................................................................................ 25 5.2 Prior/Concurrent Therapy Criteria .................................................................................................. 25 5.3 Clinical/Laboratory Criteria ............................................................................................................. 25 5.4 Specimen Submission Criteria ....................................................................................................... 26 5.5 Regulatory Criteria ......................................................................................................................... 27 6.0 STRATIFICATION FACTORS ....................................................................................................... 27 7.0 TREATMENT PLAN ...................................................................................................................... 27 7.1 Pre-Medication ............................................................................................................................... 27 7.2 Treatment – Arm 1: ABT-888 + mFOLFIRI .................................................................................... 27 7.3 Treatment – Arm 2: FOLFIRI ......................................................................................................... 28 7.4 Drug Compliance Documentation .................................................................................................. 28 7.5 Full CDUS Reporting Requirement ................................................................................................ 29 7.6 Criteria for Removal from Protocol Treatment ............................................................................... 29 7.7 Discontinuation of Treatment ......................................................................................................... 29 7.8 Follow-Up Period ............................................................................................................................ 29 8.0 TOXICITIES TO BE MONITORED AND DOSE MODIFICATIONS .............................................. 29 8.1 NCI Common Terminology Criteria for Adverse Events ................................................................ 29 8.2 Dose Modifications ......................................................................................................................... 29 8.3 Dose Modification for ABT-888 ...................................................................................................... 30 8.4 Dose Modification for FOLFIRI ...................................................................................................... 32 8.5 Dose Modifications Contacts ......................................................................................................... 34 8.6 Adverse Event Reporting ............................................................................................................... 34 9.0 STUDY CALENDAR ...................................................................................................................... 35 9.1 Arm 1: ABT-888 + mFOLFIRI ........................................................................................................ 35 9.2 Arm 2: FOLFIRB ............................................................................................................................ 36 10.0 CRITERIA FOR EVALUATION AND ENDPOINT ANALYSIS ..................................................... 38 10.1 Measurability of Lesions................................................................................................................. 38 10.2 Objective Status at Each Disease Evaluation ................................................................................ 39 10.3 Best Response ..............................................................................................................................
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