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Protocol for Protocol Amendment # To SUMMARY OF CHANGES – Protocol For Protocol Amendment # to: NCI Protocol #: 9620 Local Protocol #: CABONE NCI Version Date: 04/04/2019 Protocol Date: 04/04/2019 Please provide a list of changes from the previous CTEP approved version of the protocol. The list shall identify by page and section each change made to a protocol document with hyperlinks to the section in the protocol document. All changes shall be described in a point-by-point format (i.e., Page 3, section 1.2, replace ‘xyz’ and insert ‘abc’). When appropriate, a brief justification for the change should be included. As requested by your request for Amendment, protocol has been updated. # Section Comments Protocol 1) New Protocol Amendment/Version Date Included on the Title/Cover Page per Operations 1. Office Policy: Protocol Cover Page: Page Number(s): 5 Version Date: 04/04/2019 2) Revision of the Protocol CAEPR: 2. Section 7.1 Protocol Section(s) for Insertion of Revised CAEPR (Version 2.4, December 17, 2018): 7.1 Page Number(s): 54 • The SPEER grades have been updated. • The section below utilizes CTCAE 5.0 language unless otherwise noted. • Added New Risk: • Also Reported on XL184 Trials But With Insufficient Evidence for Attribution: Anal mucositis; Atrioventricular block complete; Budd-Chiari syndrome; Cardiac disorders - Other (hypokinetic cardiomyopathy); Chest wall pain; Death NOS; Dysphasia; Ejection fraction decreased; Gastroesophageal reflux disease; Gastrointestinal pain; General disorders and administration site conditions - Other (general physical health deterioration); Gingival pain; Hepatobiliary disorders - Other (hepatic thrombus); Hepatobiliary disorders - Other (hepatorenal syndrome); Hoarseness; Hypothermia; Pain of skin; Pelvic pain; Periodontal disease; Scrotal pain; Sinus bradycardia; Sinus tachycardia; Skin hypopigmentation; Sudden death NOS; Thyroid stimulating hormone increased; Toothache; Vaginal inflammation; Vaginal perforation i # Section Comments • Increase in Risk Attribution: • Changed to Less Likely from Also Reported on XL184 Trials But With Insufficient Evidence for Attribution: Generalized muscle weakness; Hematuria; Hypophosphatemia • Changed to Rare but Serious from Also Reported on XL184 Trials But With Insufficient Evidence for Attribution: Intracranial hemorrhage; Ischemia cerebrovascular; Stroke; Transient ischemic attacks • Decrease in Risk Attribution: • Changed to Less Likely from Likely: Voice alteration • Changed to Also Reported on XL184 Trials But With Insufficient Evidence for Attribution from Less Likely: Acute kidney injury • Provided Further Clarification: • Footnote #8 has been updated to “Respiratory hemorrhage includes Bronchopulmonary hemorrhage, Epistaxis, Hemoptysis, Laryngeal hemorrhage, Mediastinal hemorrhage, Pharyngeal hemorrhage, and Pleural hemorrhage under the RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS SOC” from “Respiratory hemorrhage includes Bronchopulmonary hemorrhage, Epistaxis, Laryngeal hemorrhage, Mediastinal hemorrhage, Pharyngeal hemorrhage, and Pleural hemorrhage under the RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS SOC.” • Musculoskeletal and connective tissue disorder - Other (muscle spasm) (CTCAE 4.0 language) is now reported as Muscle cramp. • Skin and subcutaneous tissue disorders - Other (hair color changes) (CTCAE 4.0 language) is now reported as Hair color changes. • Acute coronary syndrome is now reported as part of Chest pain - cardiac. • Endocrine disorders - Other (hypopituitarism) (CTCAE 4.0 language) is now reported as Hypopituitarism. • Gastrointestinal disorders - Other (gastroenteritis) is now reported as part of Infection. • Gastrointestinal disorders - Other (anal fissure) (CTCAE 4.0 language) is now reported as Anal fissure. • Investigations - Other (blood lactate dehydrogenase increased) (CTCAE 4.0 language) is now reported as Blood lactate dehydrogenase increased. • Investigations - Other (eosinophil count increased) (CTCAE 4.0 language) is now reported as Eosinophilia under the BLOOD AND LYMPHATIC SYSTEM DISORDERS SOC. • Investigations - Other (glucose urine present) (CTCAE 4.0 language) is now reported as Glucosuria under the RENAL AND URINARY DISORDERS SOC. • Musculoskeletal and connective tissue disorder - Other (osteonecrosis) (CTCAE 4.0 language) is now reported as Osteonecrosis. • Musculoskeletal and connective tissue disorder - Other (rhabdomyolysis) (CTCAE 4.0 language) is now reported as Rhabdomyolysis. • Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other (tumor hemorrhage) (CTCAE 4.0 language) is now reported as Tumor hemorrhage. ii # Section Comments • Nervous system disorders - Other (cerebral hematoma) is now reported as part of Hematoma under the VASCULAR DISORDERS SOC. • Nervous system disorders - Other (spinal cord compression) (CTCAE 4.0 language) is now reported as Spinal cord compression. • Renal and urinary disorders - Other (azotemia) is now part of Acute kidney injury. • Respiratory, thoracic and mediastinal disorders - Other (oropharyngeal pain) (CTCAE 4.0 language) is now reported as Oropharyngeal pain. • Skin and subcutaneous tissue disorders - Other (splinter hemorrhage) is now reported as Nail changes. PLEASE NOTE: The specific detailed changes listed here compare the new revised CAEPR Version 2.4, and associated risk information for the ICD, to the most recent CAEPR Version 2.3. If your trial contains an older CAEPR version (i.e., does NOT currently contain CAEPR Version 2.3), you MUST include a description of any additional changes resulting from migration from the older CAEPR version. iii NCI Protocol #: 9620 Local Protocol #: CABONE. TITLE: A Phase 2 Study of XL184 (Cabozantinib) in treating patients with relapsed Osteosarcomas and Ewing Sarcomas Coordinating Center: Institut Bergonié (Bordeaux, France) *Principal Investigator: Italiano Antoine, MD, PhD Institut Bergonie, Department of Medical Oncology 229 cours de l’Argonne 33000 Bordeaux, France + 33 5 56 33 33 33 + 33 5 56 33 04 85 [email protected] Co-Investigators: Maud Toulmonde MD Institut Bergonie, Department of Medical Oncology 229 cours de l’Argonne 33000 Bordeaux, France Tel : + 33 5 56 33 33 33 Fax: + 33 5 56 33 33 85 [email protected] Others Centers : Jean-Yves Blay, MD, PhD, Isabelle Ray-Coquard, MD, Perrine Marec-Berard, MD ;Christophe Bergeron, MD; Olivia Bally, MD and Medhi Brahmi, MD Centre Léon Bérard, Department of Medical Oncology 28, rue Laennec 69373 Lyon Cedex 08, France Tel: +33 4 78 78 28 28 Fax: + 33 4 78 78 29 29 [email protected] ; [email protected] ; perrine.marec- [email protected]; [email protected], [email protected], [email protected] Olivier Mir, MD, Julien Domont, MD, Axel Le Cesne, MD ; Olivier Mir, MD ; Elsa Nathalie,Gaspar, MD , and Laurence Brugieres, MD Institut Gustave Roussy, Department of Medecine 39 rue Camille Desmoulins 94800 Villejuif, France 1 NCI Protocol #: 9620 Version Date: 04/04/2019 Tel: +33 1 42 11 43 16 Fax: + 33 1 42 11 52 19 [email protected] ; [email protected] ; [email protected] ; [email protected] ; [email protected] ; Nicolas Penel, MD, Antoine Adenis, MD, PhD, Fredrick Laestadius, MD, PhD, Anne-Sophie Defachelles-Thomassin, MD, Cyril Lervat, MD, Diane Pannier, MD and Thomas Ryckewaert, MD Centre Oscar Lambret, Department of General Oncology 3, rue Frédéric Combemale BP 307 - 59020 LILLE Cedex, France Tél. : +33 3 20 29 59 20 Fax: +33 3 20 29 59 63 [email protected]; [email protected]; [email protected]; [email protected], [email protected] ; [email protected]; [email protected] Sophie Piperno-Neumann, MD; Valérie Laurence, MD, Sarah Cohen-Gogo, MD; Aurore Surun, MD; François Doz, MD; Jean Michon, MD; Irène Jimenez, MD; Isabelle Aerts, MD; Daniel Orbach, MD; Dominique Levy, MD and Gudrun Schleiermacher, MD Institut Curie, Department of Medecine 25 rue d’ULM 75005 Paris, France Tél : +33 1 44 32 46 80 Fax : +33 1 44 32 46 71 [email protected] ; [email protected]; [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected] Chevreau Christine, MD, Alberto Gomez Rocca, MD, Cécile Gandy, MD, Ewa Cottura, MD, Sarah Zahi, MD and; Valentin, MD Institut Claudius Regaud, IUCT-Oncopole - Department of Medecine 1 Avenue Irène Joliot-Curie 31052 Toulouse Cedex 09, France Tél : +33 Fax : +33 [email protected], [email protected], gandy.cecile@iuct- oncopole.fr, [email protected], [email protected] Emmanuelle Bompas, MD, Frederic Rolland, MD; Damien Vansteene, MD, Mathilde Cabart, MD and Carole Gourmelon, MD Institut de Cancérologie de l’Ouest – Site René Gauducheau Boulevard Jacques Monod 44805 Nantes St-Herblain, France Tél : +33 2 40 67 99 39 Fax : +33 2 2 NCI Protocol #: 9620 Version Date: 04/04/2019 [email protected], [email protected]; [email protected] ; [email protected], [email protected] Nicolas Isambert, MD, Sylvie Zanetta, MD and Anne-Laure Simonet Lamm Centre Georges François Leclerc 1 rue du Professeur Marion – BP 77980 21079 Dijon, France Tél : +33 3 80 73 75 06 Fax : +33 3 80 73 77 74 [email protected] ; [email protected]; [email protected] Florence
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