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Clinical Study ARRAY 818 302 Array Biopharma Inc

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Clinical Study ARRAY-818-302 PRINCIPAL INVESTIGATOR AGREEMENT I have read and understand the contents of the clinical protocol for Clinical Study ARRAY-818-302 dated 11 July 2019 and will adhere to the study requirements as presented, including all statements regarding confidentiality. In addition, I will conduct the study in accordance with the requirements of this protocol and also protect the rights, safety, privacy and well-being of study patients in accordance with the following: • International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonised Tripartite Guideline for Good Clinical Practice (GCP) E6(R1) • All applicable laws and regulations, including, without limitation, data privacy laws and regulations • Requirements for reporting serious adverse events (SAEs) defined in Section 10.9 of this protocol • Terms outlined in the Clinical Study Site Agreement My signature also acknowledges that: • Neither my subinvestigators nor I are members of the Ethics Committee (EC) reviewing this protocol, or • I and/or my subinvestigators are members of the EC, but I/we will not participate in the initial review or continuing review of this study Name of Principal Investigator Signature of Principal Investigator Date Protocol Version 8.0 3 11 July 2019 Encorafenib (BRAF V600-mutant inhibitor)/Binimetinib (MEK inhibitor) Array BioPharma Inc. Clinical Study ARRAY-818-302 PROTOCOL SYNOPSIS Title A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab with a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E-mutant Metastatic Colorectal Cancer Protocol Number ARRAY-818-302 Phase 3 Study Centers Approximately 300 international study centers Objectives Safety Lead-in In patients with BRAF V600E-mutant (BRAFV600E) metastatic colorectal cancer (mCRC): Primary: • Assess the safety/tolerability of the combination of encorafenib + binimetinib + cetuximab Secondary: • Assess the activity of encorafenib + binimetinib + cetuximab as measured by blinded independent central review (BICR)- determined and Investigator-determined objective response rate (ORR), duration of response (DOR), progression-free survival (PFS) and time to response • Characterize the pharmacokinetics (PK) of encorafenib, cetuximab, binimetinib and the active metabolite of binimetinib (AR00426032) Exploratory: • Assess the activity of encorafenib + binimetinib + cetuximab as measured by overall survival (OS) Randomized Phase 3 In patients with BRAFV600E mCRC: Primary: • Compare the activity of encorafenib + binimetinib + cetuximab (Triplet Arm) vs. irinotecan/cetuximab or 5-fluorouracil (5-FU)/folinic acid (FA)/irinotecan (FOLFIRI)/cetuximab (Control Arm) as measured by overall survival (OS) Protocol Version 8.0 4 11 July 2019 Encorafenib (BRAF V600-mutant inhibitor)/Binimetinib (MEK inhibitor) Array BioPharma Inc. Clinical Study ARRAY-818-302 • Compare the activity of encorafenib + binimetinib + cetuximab (Triplet Arm) vs. irinotecan/cetuximab or FOLFIRI/cetuximab (Control Arm) as measured by ORR per BICR Key Secondary: • Compare the activity of encorafenib + cetuximab (Doublet Arm) vs. irinotecan/cetuximab or FOLFIRI/cetuximab (Control Arm) as measured by OS Other Secondary: • Compare the Investigator-determined ORR of encorafenib + binimetinib + cetuximab (Triplet Arm) vs. irinotecan/cetuximab or FOLFIRI/cetuximab (Control Arm) • Compare the BICR-determined and Investigator-determined ORR of encorafenib + cetuximab (Doublet Arm) vs. irinotecan/cetuximab or FOLFIRI/ cetuximab (Control Arm) • Compare the BICR-determined and Investigator-determined progression-free survival (PFS) of encorafenib + binimetinib + cetuximab (Triplet Arm) vs. irinotecan/cetuximab or FOLFIRI/cetuximab (Control Arm) • Compare the BICR-determined and Investigator-determined PFS of encorafenib + cetuximab (Doublet Arm) vs. irinotecan/cetuximab or FOLFIRI/cetuximab (Control Arm) • Compare the activity of Triplet Arm vs. Doublet Arm as measured by OS • Compare BICR-determined and Investigator-determined ORR of Triplet Arm vs. Doublet Arm • Compare the BICR-determined and Investigator-determined PFS of Triplet Arm vs. Doublet Arm • Compare BICR-determined and Investigator-determined DOR of Triplet Arm vs. Control Arm, of Doublet Arm vs. Control Arm and of Triplet Arm vs. Doublet Arm • Compare BICR-determined and Investigator-determined time to response of Triplet Arm vs. Control Arm, of Doublet Arm vs. Control Arm and of Triplet Arm vs. Doublet Arm • Assess the safety/tolerability of Triplet Arm, of Doublet Arm and of Control Arm • Compare the effect on quality of life (QoL) of Triplet Arm vs. Control Arm, of Doublet Arm vs. Control Arm and of Triplet Arm vs. Doublet Arm Protocol Version 8.0 5 11 July 2019 (QFRUDIHQLE %5$)9PXWDQWLQKLELWRU %LQLPHWLQLE 0(.LQKLELWRU $UUD\%LR3KDUPD,QF &OLQLFDO6WXG\$55$< x &KDUDFWHUL]HWKH3.RIHQFRUDIHQLEFHWX[LPDEELQLPHWLQLE DQGWKHDFWLYHPHWDEROLWHRIELQLPHWLQLE $5 x $VVHVVIRUGUXJLQWHUDFWLRQVEHWZHHQHQFRUDIHQLEFHWX[LPDE ELQLPHWLQLEDQGWKHDFWLYHPHWDEROLWHRIELQLPHWLQLE $5 EDVHGRQ3.PRGHOLQJ CCI (QGSRLQWV 6DIHW\/HDGLQ 3ULPDU\ x ,QFLGHQFHRIGRVHOLPLWLQJWR[LFLWLHV '/7V x ,QFLGHQFHDQGVHYHULW\RIDGYHUVHHYHQWV $(V JUDGHG DFFRUGLQJWRWKH1DWLRQDO&DQFHU,QVWLWXWH 1&, &RPPRQ 7HUPLQRORJ\&ULWHULDIRU$GYHUVH(YHQWV &7&$( YHUVLRQ Y DQGFKDQJHVLQFOLQLFDOODERUDWRU\SDUDPHWHUV YLWDOVLJQVHOHFWURFDUGLRJUDPV (&*V HFKRFDUGLRJUDP (&+2 PXOWLJDWHGDFTXLVLWLRQ 08*$ VFDQVDQG RSKWKDOPLFH[DPLQDWLRQV x ,QFLGHQFHRIGRVHLQWHUUXSWLRQVGRVHPRGLILFDWLRQVDQG GLVFRQWLQXDWLRQVGXHWR$(V 6HFRQGDU\ x 255 E\%,&5DQG,QYHVWLJDWRU SHUWKH5HVSRQVH(YDOXDWLRQ &ULWHULDLQ6ROLG7XPRUV 5(&,67 YHUVLRQ Y GHILQHG DVWKHQXPEHURISDWLHQWVDFKLHYLQJDQRYHUDOOEHVWUHVSRQVHRI FRPSOHWHUHVSRQVH &5 RUSDUWLDOUHVSRQVH 35 GLYLGHGE\WKH WRWDOQXPEHURISDWLHQWV x '25 E\%,&5DQG,QYHVWLJDWRU GHILQHGDVWKHWLPHIURP ILUVWUDGLRJUDSKLFHYLGHQFHRIUHVSRQVHWRWKHHDUOLHVW GRFXPHQWHGGLVHDVHSURJUHVVLRQRUGHDWKGXHWRXQGHUO\LQJ GLVHDVH x 3)6 E\%,&5DQG,QYHVWLJDWRU GHILQHGDVWKHWLPHIURPILUVW GRVHWRWKHHDUOLHVWGRFXPHQWHGGLVHDVHSURJUHVVLRQRUGHDWK GXHWRDQ\FDXVH x 7LPHWRUHVSRQVH E\%,&5DQG,QYHVWLJDWRU GHILQHGDVWKH WLPHIURPILUVWGRVHWRILUVWUDGLRJUDSKLFHYLGHQFHRIUHVSRQVH 3URWRFRO9HUVLRQ -XO\ Encorafenib (BRAF V600-mutant inhibitor)/Binimetinib (MEK inhibitor) Array BioPharma Inc. Clinical Study ARRAY-818-302 • PK parameters of encorafenib, cetuximab, binimetinib and the active metabolite of binimetinib (AR00426032) Exploratory: • OS, defined as the time from first dose to death due to any cause Randomized Phase 3 Primary: • OS, defined as the time from randomization to death due to any cause, of Triplet Arm vs. Control Arm • Confirmed ORR (by BICR) per RECIST, v1.1 of Triplet Arm vs. Control Arm Key Secondary: • OS of Doublet Arm vs. Control Arm Other Secondary: • Confirmed ORR (by Investigator) per RECIST, v1.1 of Triplet Arm vs. Control Arm • Confirmed ORR (by BICR and Investigator) per RECIST, v1.1 of Doublet Arm vs. Control Arm • PFS (by BICR and Investigator), defined as the time from randomization to the earliest documented disease progression or death due to any cause, of Triplet Arm vs. Control Arm • PFS (by BICR and Investigator) of Doublet Arm vs. Control Arm • OS of Triplet Arm vs. Doublet Arm • Confirmed ORR (by BICR and Investigator) per RECIST, v1.1 of Triplet Arm vs. Doublet Arm • PFS (by BICR and Investigator) of Triplet Arm vs. Doublet Arm • DOR (by BICR and Investigator) of Triplet Arm vs. Control Arm, of Doublet Arm vs. Control Arm and of Triplet Arm vs. Doublet Arm • Time to response (by BICR and Investigator), defined as the time from randomization to first radiographic evidence of response, of Triplet Arm vs. Control Arm, of Doublet Arm vs. Control Arm and of Triplet Arm vs. Doublet Arm Protocol Version 8.0 7 11 July 2019 (QFRUDIHQLE %5$)9PXWDQWLQKLELWRU %LQLPHWLQLE 0(.LQKLELWRU $UUD\%LR3KDUPD,QF &OLQLFDO6WXG\$55$< x ,QFLGHQFHDQGVHYHULW\RI$(VJUDGHGDFFRUGLQJWR1&, &7&$(YDQGFKDQJHVLQFOLQLFDOODERUDWRU\SDUDPHWHUV YLWDOVLJQV(&*V(&+208*$VFDQVDQGRSKWKDOPLF H[DPLQDWLRQV x &KDQJHIURPEDVHOLQHLQWKH(XURSHDQ2UJDQL]DWLRQIRU 5HVHDUFKDQG7UHDWPHQWRI&DQFHU (257& 4XDOLW\RI/LIH 4XHVWLRQQDLUHIRU&DQFHU3DWLHQWV 4/4& )XQFWLRQDO $VVHVVPHQWRI&DQFHU7KHUDS\&RORQ&DQFHU )$&7& (XUR4RO'/ (4'/ DQG3DWLHQW*OREDO,PSUHVVLRQRI &KDQJH 3*,& RI7ULSOHW$UPYV&RQWURO$UPRI'RXEOHW $UPYV&RQWURO$UPDQGRI7ULSOHW$UPYV'RXEOHW$UP x 0RGHOEDVHG3.SDUDPHWHUVRIHQFRUDIHQLEFHWX[LPDE ELQLPHWLQLEDQGWKHDFWLYHPHWDEROLWHRIELQLPHWLQLE $5 x 0RGHOEDVHG3.DVVHVVPHQWRIGUXJGUXJLQWHUDFWLRQVEHWZHHQ HQFRUDIHQLEFHWX[LPDEELQLPHWLQLEDQGWKHDFWLYHPHWDEROLWH RIELQLPHWLQLE $5 CCI 'HVLJQ 7KLVLVDPXOWLFHQWHUUDQGRPL]HGRSHQODEHODUP3KDVHVWXG\
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    INFORMATION TRANSMISE SOUS L’AUTORITE DE L’ANSM Lettre aux professionnels de Santé Septembre 2013 Communication aux professionnels de santé concernant les restrictions d’indications des médicaments par voie orale contenant : dihydroergotamine, dihydroergocristine, dihydroergocryptine-caféine, nicergoline A destination des : neurologues, ophtalmologistes, cardiologues, chirurgiens vasculaires, phlébologues, angéiologues, gériatres, médecins généralistes, pharmaciens (ville + hôpital) , CRPV Madame, Monsieur, Cher Confrère, En accord avec l’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) et l’Agence européenne du médicament (EMA), nous vous informons que les médicaments contenant de la dihydroergotamine, de la dihydroergocristine, de la dihydroergocryptine-caféine ou de la nicergoline ne devront plus être utilisés dans les indications suivantes : Dihydroergotamine (SEGLOR, TAMIK, IKARAN, DIHYDROERGOTAMINE AMDIPHARM): • Traitement de fond de la migraine. • Traitement de l’hypotension orthostatique. • Amélioration des symptômes en rapport avec l'insuffisance veinolymphatique (jambes lourdes, douleurs, impatience du primo-decubitus). Dihydroergocristine (ISKEDYL): • Traitement à visée symptomatique du déficit pathologique cognitif et neurosensoriel chronique du sujet âgé (à l’exclusion de la maladie d’Alzheimer et des autres démences). • Traitement d’appoint des baisses d’acuité visuelle et troubles présumés du champ visuel d’origine vasculaire. • Rétinopathies aigües d’origine vasculaire Dihydroergocryptine-caféine (VASOBRAL) : • Traitement d'appoint à visée symptomatique du déficit pathologique cognitif et neurosensoriel chronique du sujet âgé (à l'exclusion de la maladie d'Alzheimer et des autres démences). • Traitement d'appoint du syndrome de Raynaud. Nicergoline (SERMION, NICERGOLINE BIOGARAN, NICERGOLINE EG, NICERGOLINE MYLAN, NICERGOLINE TEVA): • Traitement d'appoint à visée symptomatique du déficit pathologique cognitif et neurosensoriel chronique du sujet âgé (à l'exclusion de la maladie d'Alzheimer et des autres démences).
  • FOI Reference: FOI 414 - 2021

    FOI Reference: FOI 414 - 2021

    FOI Reference: FOI 414 - 2021 Title: Researching the Incidence and Treatment of Melanoma and Breast Cancer Date: February 2021 FOI Category: Pharmacy FOI Request: 1. How many patients are currently (in the past 3 months) undergoing treatment for melanoma, and how many of these are BRAF+? 2. In the past 3 months, how many melanoma patients (any stage) were treated with the following: • Cobimetinib • Dabrafenib • Dabrafenib AND Trametinib • Encorafenib AND Binimetinib • Ipilimumab • Ipilimumab AND Nivolumab • Nivolumab • Pembrolizumab • Trametinib • Vemurafenib • Vemurafenib AND Cobimetinib • Other active systemic anti-cancer therapy • Palliative care only 3. If possible, could you please provide the patients treated in the past 3 months with the following therapies for metastatic melanoma ONLY: • Ipilimumab • Ipilimumab AND Nivolumab • Nivolumab • Pembrolizumab • Any other therapies 4. In the past 3 months how many patients were treated with the following for breast cancer? • Abemaciclib + Anastrozole/Exemestane/Letrozole • Abemaciclib + Fulvestrant • Alpelisib + Fulvestrant • Atezolizumab • Bevacizumab [Type text] • Eribulin • Everolimus + Exemestane • Fulvestrant as a single agent • Gemcitabine + Paclitaxel • Lapatinib • Neratinib • Olaparib • Palbociclib + Anastrozole/Exemestane/Letrozole • Palbociclib + Fulvestrant • Pertuzumab + Trastuzumab + Docetaxel • Ribociclib + Anastrozole/Exemestane/Letrozole • Ribociclib + Fulvestrant • Talazoparib • Transtuzumab + Paclitaxel • Transtuzumab as a single agent • Trastuzumab emtansine • Any other
  • United States Patent (19) 11 Patent Number: 6,060,499 Plachetka (45) Date of Patent: *May 9, 2000

    United States Patent (19) 11 Patent Number: 6,060,499 Plachetka (45) Date of Patent: *May 9, 2000

    US006060499A United States Patent (19) 11 Patent Number: 6,060,499 Plachetka (45) Date of Patent: *May 9, 2000 54). ANTI-MIGRAINE METHODS AND Centonze, “Evaluation of the efficacy of oral Sumatriptan in COMPOSITIONS USING 5-HTAGONSTS the management of migraine attacks. Clinical Results' WITH LONG-ACTING NSAIDS (1995) La Clinica Teraputica, vol. 146(11), 721-728 (Article in the Italian language, Citation to English language 75 Inventor: John R. Plachetka, Chapel Hill, N.C. abstract only at 727). Dechant, “Sumatriptan. A review of its Pharmacodynamic 73 Assignee: Pozen, Inc., Chapel Hill, N.C. Properties, and Therapeutic Efficacy in the Acute Treatment of Migraine and Cluster Headache” (1992) Drugs, vol. 43(5) * Notice: This patent is Subject to a terminal dis 776-798. claimer. Klapper, “Toward a Standard Drug Formulary for the Treat ment of Headache” (1995) Headache, Apr., 1995, 225-227. 21 Appl. No.: 09/151,912 Oral Sumatriptan Group, “Sumatriptan-An Oral Dose-de fining Study” (1991) Eur: Neurol., vol. 31, 300–305. 22 Filed: Sep. 11, 1998 Thomson, “A Study to Compare Oral Sumatriptan with Oral Aspirin plus Oral Metoclopramide in the Acute Treatment of Related U.S. Application Data Migraine” (1992) Eur: Neurol., vol. 32, 177-184. 62 Division of application No. 08/907,826, Aug. 14, 1997, Pat. Todd, "Naproxen A reappraisal of its Pharmacology, and No. 5,872,145. Therapeutic Use in Rheumatic Diseases and pain States' 60 Provisional application No. 60/024,129, Aug. 16, 1996. (1990) Drugs, vol. 40(1), 91-137. Tokola, “Effects of migraine attack and metoclopramide on (51) Int.
  • Summary Risk Management Plan for Braftovi

    Summary Risk Management Plan for Braftovi

    Summary of the risk management plan Summary of the risk management plan for BRAFTOVI This is a summary of the risk management plan (RMP) for BRAFTOVI when administered in combination with MEKTOVI or cetuximab. The RMP details important risks of BRAFTOVI in combination with MEKTOVI or cetuximab, how these risks can be minimised, and how more information will be obtained about BRAFTOVI in combination with MEKTOVI or cetuximab risks and uncertainties (missing information). Summary of product characteristics (SmPC) for BRAFTOVI and its package leaflets give essential information to healthcare professionals and patients on how BRAFTOVI should be used. This summary of the RMP for BRAFTOVI when administered in combination with MEKTOVI or cetuximab should be read in the context of all this information including the assessment reports of the evaluation and the plain-language summary, all of which are part of the European Public Assessment Report (EPAR). Important new concerns or changes to current concerns will be included in future updates of the RMP for BRAFTOVI. I. The medicine and what it is used for BRAFTOVI is authorised in combination with MEKTOVI for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see SmPC for the full indication). The active substance of BRAFTOVI is encorafenib and of MEKTOVI is binimetinib and both are given by the oral route of administration. BRAFTOVI in combination with cetuximab is authorised for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy. Cetuximab is given by intravenous infusion.