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A Study of Atezolizumab Compared With Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Containing Therapy (IPSOS)

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ClinicalTrials.gov Identifier: NCT03191786
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for any platinum-doublet chemotherapy due to poor performance status (Eastern Cooperative Oncology Group [ECOG] performance status of 2-3).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Drug: Vinorelbine Drug: Gemcitabine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab Compared With Chemotherapy in Patients With Treatment Naïve Advanced or Recurrent (Stage IIIb Not Amenable for Multimodality Treatment) or Metastatic (Stage IV) Non-Small Cell Lung Cancer Who Are Deemed Unsuitable for Platinum-Containing Therapy
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : January 20, 2021
Estimated Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Atezolizumab
Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered via IV infusion once every three weeks (QW3).
Other Name: MPDL3280A

Active Comparator: Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
Participants will receive single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice.
Drug: Vinorelbine
Vinorelbine will be administered per relevant local guidelines and Summary of Product Characteristics (SmPC) management.
Other Name: Navelbine®

Drug: Gemcitabine
Gemcitabine will be administered per relevant local guidelines and SmPC management.
Other Name: Gemzar®




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization up to death from any cause (up to approximately 3.5 years) ]

Secondary Outcome Measures :
  1. Percentage of Participants Who Are Alive at Specified Timepoints [ Time Frame: 6, 12, 18 and 24 months ]
  2. Percentage of Participants With Objective Response, as Determined by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1) [ Time Frame: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 3.5 years) ]
    Objective response is defined as partial response (PR) plus complete response (CR).

  3. Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1 [ Time Frame: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 3.5 years) ]
  4. Duration of Response, as Determined by the Investigator Using RECIST v1.1 [ Time Frame: Time from the first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever occurs first (up to approximately 3.5 years) ]
  5. Percentage of Participants With Adverse Events (AEs) [ Time Frame: From randomization up to approximately 3.5 years ]
  6. Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score [ Time Frame: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 3.5 years) (Cycle length = 21 days) ]
  7. Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score [ Time Frame: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 3.5 years) (Cycle length = 21 days) ]
  8. Time to Deterioration in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC QLQ-C30 Score [ Time Frame: From baseline up to approximately 3.5 years ]
  9. Time to Deterioration in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score [ Time Frame: From baseline up to approximately 3.5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC as per the American Joint Committee on Cancer (AJCC) 7th edition
  • No sensitizing epidermal growth factor receptor (EGFR) mutation (L858R or exon 19 deletions) or anaplastic lymphoma kinase (ALK) fusion oncogene detected
  • No prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC as per the AJCC 7th edition
  • Life expectancy greater than or equal to (>/=) 8 weeks
  • Deemed unsuitable by the investigator for any platinum-doublet chemotherapy due to poor performance status (ECOG performance status of 2-3). However, participants >= 70 years of age who have an ECOG PS of 0 or 1 may be included due to: a) substantial comorbidities; b) contraindication(s) for any platinum-doublet chemotherapy
  • Representative formalin-fixed paraffin-embedded (FPPE) tumor tissue block obtained during course of disease (archival tissue) or at screening
  • Participants with treated, asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: Measurable disease outside CNS; Only supratentorial and cerebellar metastases allowed; No ongoing requirement for corticosteroids as therapy for CNS disease; No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to randomization; No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
  • Adequate hematologic and end organ function
  • Female participants of childbearing potential randomized to the atezolizumab treatment arm agree to use protocol defined methods of contraception

Exclusion Criteria:

Cancer-Specific Exclusion Criteria:

  • Participants younger than 70 years who have an ECOG performance status of 0 or 1
  • Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation of the brain during screening and prior radiographic assessments
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Uncontrolled or symptomatic hyerpcalcemia (ionized calcium > 1.5 mmol/L or calcium >12 mg/dL or corrected serum calcium >ULN)
  • History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (v4.0) Grade 3 or higher toxicities due to any prior therapy (example [e.g.], radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
  • Participants who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy

General Medical Exclusion Criteria:

  • History of autoimmune disease except autoimmune-related hypothyroidism and controlled Type I diabetes mellitus
  • History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
  • Known positivity for human immunodeficiency virus (HIV)
  • Known active hepatitis B or hepatitis C
  • Active tuberculosis
  • Severe infections within 4 weeks prior to randomization
  • Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
  • Major surgical procedure other than for diagnosis within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study
  • Prior allogeneic bone marrow transplantation or solid organ transplant
  • Participants with an illness or condition that may interfere with capacity or compliance with the study protocol, as per investigator's judgment
  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to randomization

Exclusion Criteria Related to Atezolizumab:

  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • Oral or IV antibiotic treatment
  • Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to randomization
  • Treatment with systemic corticosteroids or other immunosuppressive medications
  • Participants not willing to stop treatment with traditional herbal medicines

Exclusion Criteria Related to Chemotherapy:

  • Known sensitivity and contraindications to the 2 comparative chemotherapy agents (that is [i.e.] vinorelbine, oral or intravenous, and gemcitabine, intravenous)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191786


Contacts
Contact: Reference Study ID Number: MO29872 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Locations
Argentina
Fundación CENIT para la Investigación en Neurociencias Recruiting
Buenos Aires, Argentina, C1125ABD
Hospital Privado de Comunidad Recruiting
Mar del Plata, Argentina, 7600
Centro de Investigacion; Clinica - Clinica Viedma S.A. Recruiting
Viedma, Argentina, R8500ACE
Belgium
UZ Brussel Recruiting
Brussel, Belgium, 1090
Grand Hôpital de Charleroi Notre Dame Recruiting
Charleroi, Belgium, 6000
UZ Leuven Gasthuisberg Recruiting
Leuven, Belgium, 3000
Brazil
Hospital São Lucas da PUCRS Active, not recruiting
Porto Alegre, RS, Brazil, 90610-000
Hospital Nossa Senhora da Conceicao Recruiting
Porto Alegre, RS, Brazil, 91350-200
Instituto do Cancer do Estado de Sao Paulo - ICESP Recruiting
Sao Paulo, SP, Brazil, 01246-000
Bulgaria
Umhat Dr Georgi Stranski; Clinic of Chemotherapy Recruiting
Pleven, Bulgaria, 5800
Complex Oncology Center (COC)-Plovidiv Recruiting
Plovdiv, Bulgaria, 4000
Complex Oncological Center-Ruse EOOD; Department of Medical Oncology Recruiting
Ruse, Bulgaria, 7000
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD Recruiting
Sofia, Bulgaria, 1527
Canada, British Columbia
BCCA-Vancouver Cancer Centre Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, New Brunswick
Regional health authority A vitalite health network Active, not recruiting
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
Ottawa Hospital Research Institute Active, not recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Sault Area Hospitals Recruiting
Sault Ste Marie, Ontario, Canada, P6A 2C4
Princess Margaret Cancer Center Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Canada, Quebec
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology Completed
Montreal, Quebec, Canada, H3T 1E2
China
Anhui Provincial Hospital Recruiting
Anhui, China, 230001
Beijing Cancer Hospital Not yet recruiting
Beijing, China, 100142
Hu Nan Provincial Cancer Hospital Recruiting
Changsha, China, 410006
The Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou City, China, 310009
Shanghai Chest Hospital Active, not recruiting
Shanghai, China, 200030
Tianjin Cancer Hospital Recruiting
Tianjin, China, 300060
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center Recruiting
Wuhan, China, 430023
Colombia
Fundacion Cardioinfantil Recruiting
Bogota, Colombia
Oncomedica S.A. Recruiting
Monteria, Colombia, 230002
Oncólogos de Occidente Recruiting
Pereira, Colombia, 600004
Czechia
Fakultni nemocnice Brno; Klinika nemocí plicních a TBC Recruiting
Brno, Czechia, 625 00
Fakultni nemocnice Olomouc; Pneumologicka klinika Recruiting
Olomouc, Czechia, 775 20
Denmark
Sjællands Universitetshospital, Næstved; Onkologisk Afdeling Recruiting
Naestved, Denmark, 4700
Odense Universitetshospital, Onkologisk Afdeling R Recruiting
Odense C, Denmark, 5000
Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed Recruiting
Roskilde, Denmark, 4000
Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie Recruiting
Berlin, Germany, 13125
LungenClinic Großhansdorf Active, not recruiting
Großhansdorf, Germany, 22927
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II Recruiting
Halle, Germany, 06120
Fachklinik für Lungenerkrankungen Recruiting
Immenhausen, Germany, 34376
Klinikum der Philipps-Universität Marburg Recruiting
Marburg, Germany, 35032
Asklepios Klinik München-Gauting Recruiting
München-Gauting, Germany, 82131
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie Recruiting
Regensburg, Germany, 93053
Universitätsklinikum Tübingen; Medizinische Klinik, Innere Medizin II Recruiting
Tübingen, Germany, 72076
India
Indraprastha Apollo Hospitals Not yet recruiting
New Delhi, Delhi, India, 110076
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology Recruiting
New Delhi, Delhi, India, 110085
Tata Memorial Hospital; Dept of Medical Oncology Active, not recruiting
Mumbai, Maharashtra, India, 400012
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz Recruiting
Mumbai, Maharashtra, India, 400053
HCG Manavata Cancer Centre Not yet recruiting
Nashik, Maharashtra, India, 422002
SMS Medical College Hospital Withdrawn
Jaipur, Rajasthan, India, 302004
Christian Medical College & Hospital; Medicine Withdrawn
Vellore, Tamil NADU, India, 632004
TATA Medical Centre; Medical Oncology Withdrawn
Kolkata, WEST Bengal, India, 700156
Tata Medical Center; Department of Radiation Oncology Recruiting
Kolkata, WEST Bengal, India, 700160
Indo-American Cancer Hospital & Research Center Not yet recruiting
Hyderabad, India, 500 034
P.D. Hinduja Nat. Hospital & Med. Research Centre Recruiting
Mahim (West), India, 400016
Max Super Speciality Hospital Not yet recruiting
New Delhi, India, 110017
Grant Medical Foundation, Ruby Hall Clinic Not yet recruiting
Pune, India, 411001
Deenanath Mangeshkar Hospital & Research Centre Not yet recruiting
Pune, India, 411004
Ireland
Mater Misericordiae University Hospital - Institute for Cancer Research Recruiting
Dublin, Ireland, 7
University Hospital Limerick - Clinical Trials Department Recruiting
Limerick, Ireland
Italy
AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico Withdrawn
Napoli, Campania, Italy, 80131
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica Active, not recruiting
Ravenna, Emilia-Romagna, Italy, 48100
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1 Recruiting
Roma, Lazio, Italy, 00152
Irccs Ospedale San Raffaele;Oncologia Medica Recruiting
Milano, Lombardia, Italy, 20132
Azienda Ospedaliera San Gerardo di Monza Active, not recruiting
Monza MI, Lombardia, Italy, 20900
Kazakhstan
Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department Active, not recruiting
Almaty, Kazakhstan, 050022
Almaty Cancer Hospital; Chemotherapy department Recruiting
Almaty, Kazakhstan, 050060
Oncology centre of Astana; Chemotherapy department Not yet recruiting
Astana, Kazakhstan, 010000
Luxembourg
Centre Hospitalier de Luxembourg Recruiting
Luxembourg, Luxembourg, 1210
Mexico
Health Pharma Professional Research Recruiting
CD Mexico, Mexico CITY (federal District), Mexico, 03810
Oncologico Potosino Active, not recruiting
San Luis Potosí, SAN LUIS Potosi, Mexico, 78250
Centro Estatal de Cancerologia de Chihuahua; ONCOLOGY Recruiting
Chihuahua, Mexico, 31000
Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii Recruiting
Otwock, Poland, 05-400
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie; Klinika Nowotworow Pluca i Klatki Piersiowej Recruiting
Warszawa, Poland, 02-781
Portugal
Hospital Geral; Servico de Pneumologia Recruiting
Coimbra, Portugal, 3041-801
IPO do Porto; Servico de Oncologia Medica Recruiting
Porto, Portugal, 4200-072
Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala Active, not recruiting
Cluj Napoca, Romania, 400015
Centrul de Radioterapie AMETHYST Recruiting
Floresti, Romania, 407280
Oncocenter Timisoara Active, not recruiting
Timişoara, Romania, 300166
Slovakia
Specializovana nemocnica sv. Svorada Zobor, n.o. Recruiting
Nitra, Slovakia, 949 88
Fakultna nemocnica Trnava Recruiting
Trnava, Slovakia, 917 75
Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Active, not recruiting
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia Recruiting
Reus, Tarragona, Spain, 43204
Hospital de Cruces; Servicio de Oncologia Active, not recruiting
Bilbao, Vizcaya, Spain, 48903
Institut Catala d Oncologia Hospital Duran i Reynals Recruiting
Barcelona, Spain, 08908
Hospital Universitario de la Princesa; Servicio de Oncologia Recruiting
Madrid, Spain, 28006
Hospital Universitario Clínico San Carlos; Servicio de Oncologia Completed
Madrid, Spain, 28040
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia Active, not recruiting
Malaga, Spain, 29010
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia Recruiting
Murcia, Spain, 30008
Hospital Universitario Virgen Macarena; Servicio de Oncologia Active, not recruiting
Sevilla, Spain, 41009
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia Active, not recruiting
Valencia, Spain, 46015
Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI) Recruiting
Bellinzona, Switzerland, 6500
Spital Thun; Medizinische Klinik Active, not recruiting
Thun, Switzerland, 3600
Kantonsspital Winterthur; Medizinische Onkologie Recruiting
Winterthur, Switzerland, 8401
United Kingdom
Clatterbridge Cancer Centre Recruiting
Bebington, United Kingdom, CH63 4JY
Birmingham Heartlands Hospital; Department of Haematology Recruiting
Birmingham, United Kingdom, B9 5SS
New Victoria Hospital Recruiting
Glasgow, United Kingdom, G42 9LF
Barts and The London Withdrawn
London, United Kingdom, EC1M 6BQ
UCLH - Clinical Trials Pharmacy B&D Centre Recruiting
London, United Kingdom, N7 9NH
Christie Hospital Nhs Trust; Medical Oncology Recruiting
Manchester, United Kingdom, M2O 4BX
Royal Cornwall Hospital; Dept of Clinical Oncology Recruiting
Truro, United Kingdom, TR1 3LJ
YORK DISTRICT HOSPITAL; Haematology/Oncology Department Recruiting
York, United Kingdom, YO31 8HE
Vietnam
Bach Mai Hospital Recruiting
Hanoi, Vietnam, 10000
K hospital Not yet recruiting
Hanoi, Vietnam, 10000
Cho Ray Hospital Recruiting
Hochiminh city, Vietnam, 70000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03191786     History of Changes
Other Study ID Numbers: MO29872
2015-004105-16 ( EudraCT Number )
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Atezolizumab
Vinorelbine
Vinblastine
Antibodies
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators