BRUIN CLL-321: Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Sponsor
Loxo Oncology, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04666038
Collaborator
Eli Lilly and Company (Industry)
250
201
2
38.8
1.2
0

Study Details

Study Description

Brief Summary

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

Detailed Description

This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm

  1. in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A and Arm B.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Eligible patients will be randomized in 1:1 into Arm A or Arm B. Patients randomized to Arm B who have disease progression (PD) confirmed by independent review committee (IRC) may be eligible to crossover into Arm A.Eligible patients will be randomized in 1:1 into Arm A or Arm B. Patients randomized to Arm B who have disease progression (PD) confirmed by independent review committee (IRC) may be eligible to crossover into Arm A.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
Actual Study Start Date :
Mar 9, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A (LOXO-305)

Orally

Drug: LOXO-305
Oral LOXO-305
Other Names:
  • Pirtobrutinib
  • Active Comparator: Arm B (Idelalisib plus rituximab [IdelaR] or bendamustine plus rituximab [BR])

    Investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR).

    Drug: Idelalisib
    Oral
    Other Names:
  • Zydelig
  • Drug: Bendamustine
    IV
    Other Names:
  • Treanda, Treakisym, Ribomustin, Levact
  • Drug: Rituximab
    IV
    Other Names:
  • Rituxan, MabThera, Truxima
  • Outcome Measures

    Primary Outcome Measures

    1. To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B) [Up to approximately 36 months]

      Assessed per iwCLL 2018

    Secondary Outcome Measures

    1. To evaluate the effectiveness of Arm A compared to Arm B based on Overall Response Rate (ORR) [Up to approximately 36 months]

      Assessed per iwCLL 2018

    2. To evaluate the effectiveness of Arm A compared to Arm B based on Overall Survival (OS) [Up to approximately 36 months]

      Assessed by survival

    3. To evaluate the effectiveness of Arm A compared to Arm B based on Time to Next Treatment (TTNT) [Up to approximately 36 months]

      Defined as time from randomization to next systemic anticancer therapy for CLL/SLL

    4. Time to worsening (TTW) of CLL/SLL related symptoms [Up to approximately 36 months]

      Using symptom questions identified from the EORTC item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms

    5. Time to worsening (TTW) of physical function [Up to approximately 36 months]

      Using the 5 physical function items identified from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) questionnaire (also known as the EORTC IL 19 questionnaire), physical function will be measured. The range of raw scores for these items could be from 0-20 with the highest score indicating worst function.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria

    • Previously treated with a covalent BTK inhibitor

    • Eastern Cooperative Oncology Group (ECOG) 0-2

    • Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support

    • Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 14 days of Cycle 1 Day 1

    • Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 14 days of C1D1. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ (75 × 109/L).

    • AST and ALT ≤ 3.0 x upper limit of normal (ULN).

    • Total bilirubin ≤ 1.5 x ULN.

    • Estimated creatinine clearance of ≥ 30 mL/min.

    Exclusion Criteria:
    • Known or suspected Richter's transformation at any time preceding enrollment.

    • Known or suspected history of central nervous system (CNS) involvement by CLL/SLL

    • Ongoing drug-induced liver injury

    • Active uncontrolled auto-immune cytopenia

    • Significant cardiovascular disease

    • History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days

    • Active hepatitis B or hepatitis C

    • Known active cytomegalovirus (CMV) infection.

    • Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.

    • Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.

    • Clinically significant active malabsorption syndrome or inflammatory bowel disease

    • Prior exposure to non-covalent (reversible) BTK inhibitor.

    • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.

    • Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers and/or strong P-glycoprotein (P-gp) inhibitors

    • Vaccination with a live vaccine within 28 days prior to randomization

    • Patients with the following hypersensitivity:

    1. Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305, idelalisib, and bendamustine

    2. Prior significant hypersensitivity to rituximab

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern Cancer Center, P.C. Daphne Alabama United States 36526
    2 Mitchell Cancer Institute -University of South Alabama Mobile Alabama United States 36604
    3 Palo Verde Hematology Oncology Glendale Arizona United States 85304
    4 Arizona Oncology Associates, P.C. - HOPE Tucson Arizona United States 85711
    5 Orange Coast Memorial Medical Center Fountain Valley California United States 92708
    6 California Research Institute Los Angeles California United States 90027
    7 Rocky Mountain Cancer Center Aurora Colorado United States 80012
    8 Medical Oncology Hematology Consultants, PA Newark Delaware United States 19713
    9 Boca Raton Regional Hospital Boca Raton Florida United States 33486
    10 Cancer Specialists of North Florida -St Augustine Jacksonville Florida United States 32256
    11 Oncology-Hematology Associates of West Broward Tamarac Florida United States 33321
    12 WellStar Health System Marietta Georgia United States 30060
    13 Rush University Medical Center Chicago Illinois United States 60612
    14 Illinois Cancer Specialists-Niles Niles Illinois United States 60714
    15 Community Health Network Indianapolis Indiana United States 46250
    16 Arnett Cancer Center Lafayette Indiana United States 47904
    17 University of Kentucky Markey Cancer Center Lexington Kentucky United States 40563
    18 Norton Cancer Institute Louisville Kentucky United States 40207
    19 Mercy Health-Paducah Medical Oncology and Hematology Paducah Kentucky United States 42003
    20 Cancer Center Office of Clinical Research New Orleans Louisiana United States 70112
    21 Greenebaum Comprehensive Cancer Center Baltimore Maryland United States 21201
    22 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    23 Ascension St. John Hospital Grosse Pointe Woods Michigan United States 48236
    24 Minnesota Oncology/Hematology PA Saint Paul Minnesota United States 55102
    25 St. Vincent Frontier Cancer Center Billings Montana United States 59102
    26 Nebraska Hematology-Oncology Lincoln Nebraska United States 68506
    27 New Jersey Center for Cancer Research Brick New Jersey United States 08724
    28 Memorial Sloan Kettering Cancer Center New York New York United States 10021
    29 University of Rochester Rochester New York United States 14642
    30 Clinical Research Alliance, Inc. Westbury New York United States 11590
    31 Oncology Hematology Care Inc Cincinnati Ohio United States 45236
    32 Willamette Valley Cancer Institute and Research Center Eugene Oregon United States 97401
    33 Texas Oncology - Amarillo Amarillo Texas United States 79106
    34 Texas Oncology Cancer Center Austin Texas United States 78705
    35 Texas Oncology - Medical City Dallas Dallas Texas United States 75230
    36 Texas Oncology - Dallas Presbyterian Hospital Dallas Texas United States 75231
    37 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    38 Texas Oncology Fort Worth Fort Worth Texas United States 76104
    39 The Center for Cancer and Blood Disorders Fort Worth Texas United States 76104
    40 Texas Oncology - McAllen McAllen Texas United States 78503
    41 Texas Oncology - San Antonio Medical Center San Antonio Texas United States 78240
    42 Texas Oncology - Tyler Tyler Texas United States 75702
    43 Virginia Cancer Specialists, PC Gainesville Virginia United States 20155
    44 Oncology and Hematology Associates of Southwest Virginia Inc Roanoke Virginia United States 24014
    45 Northwest Medical Specialties, PLLC Tacoma Washington United States 98405
    46 St Vincent's Hospital Darlinghurst New South Wales Australia 2010
    47 The St. George Hospital Kogarah New South Wales Australia 2217
    48 Ingham Institute of Medical Research Liverpool New South Wales Australia NSW2170
    49 Westmead Hospital Wentworthville New South Wales Australia 2145
    50 Royal Perth Hospital Perth Western Australia Australia 6000
    51 Ordensklinikum Linz GmbH Elisabethinen Linz Oberösterreich Austria 4020
    52 Uniklinikum Salzburg Salzburg Osterreich Austria 5020
    53 CHR Verviers-Onco Verviers Liege Belgium 4800
    54 VITAZ Sint-Niklaas Oost-Vlaanderen Belgium B-9100
    55 AZ Delta Roeselare West Flanders Belgium 8800
    56 Universitair Ziekenhuis Gent Gent Belgium 9000
    57 Groupe Jolimont Haine-Saint-Paul Belgium 7100
    58 AZ St-Elisabeth Herentals Belgium 2200
    59 Clinique Saint Pierre Ottignies Ottignies Belgium 1340
    60 Queen Elizabeth II Health Sciences Center Halifax Nova Scotia Canada B3H 1V7
    61 Southlake Regional Health Centre Newmarket Ontario Canada L3Y 2P9
    62 Princess Margaret Hospital Toronto Ontario Canada M5G 1Z5
    63 Peking University First Hospital Beijing Beijing China 100034
    64 Peking University Third Hospital Beijing Beijing China 100191
    65 Xuanwu Hospital Capital Medical University Xicheng District Beijing China 100053
    66 Southern Medical University Nanfang Hospital Guangzhou Guangdong China 510515
    67 Henan Cancer Hospital Zhengzhou Henan China 450008
    68 The Affiliated Hospital of Xuzhou Medical College Xuzhou Jiangsu China 221006
    69 The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
    70 The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
    71 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China
    72 Affiliated Tumor Hospital of Xinjiang Medical University Ürümqi Xinjiang China 830002
    73 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
    74 Zhejiang Provincial Taizhou Hospital Linhai Zhejiang China 317000
    75 Beijing Hospital Beijing China 100730
    76 Blood Institute of the Chinese Academy of Medical science Tianjin China 300020
    77 University Hospital Split Split Croatia 21000
    78 Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb Zagreb Croatia
    79 Fakultni nemocnice Brno Brno Czechia 62500
    80 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    81 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia 12808
    82 CHU De Grenoble Hopital Albert Michallon Grenoble Cedex 09 France 38043
    83 Hospital AVICENNE Bobigny Cedex France 93 009
    84 Centre Hospitalier Lyon Sud Pierre Benite Cedex France 69495
    85 CHD Vendee La Roche-sur-Yon La Roche Sur Yon France 85000
    86 Chu Nimes/Institut De Cancerologie Du Gard Nîmes Nimes France 30900
    87 Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen Rouen Seine-Maritime France 76038
    88 CHRU De Tours Tours Tours Cedex 9 France 37044
    89 Centre Hospitalier de la Côte Basque Bayonne France 64109
    90 Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux France 33076
    91 CHRU de Brest - Hôpital Morvan Brest cedex France 29609
    92 Centre Hospitalier du Mans Le Mans France 72000
    93 Hopital Saint Vincent De Paul Lille cedex France 59020
    94 Ch Perpignan Perpignan France 66046
    95 Pole Regionalde Cancérologie(CHU de Poitiers) Politiers France 86021
    96 Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg Germany 69120
    97 Uniklinik Köln Kerpener Köln Germany 50937
    98 Universitätsklinikum Schleswig-Holstein Kiel Schleswig-Holstein Germany 24105
    99 Lübecker Onkologische Schwerpunktpraxis Lübeck Schleswig-Holstein Germany 23562
    100 Mater Misericordiae Hospital Dublin 7 Ireland
    101 St James's Hosptial Dublin 8 Ireland D08 NHY1
    102 Beaumont Hospital, Dublin Dublin Ireland DUBLIN 9
    103 Rabin Medical Center Petah Tikva HaMerkaz Israel
    104 Soroka Medical Center Beer Sheva Israel 8457108
    105 Laniado Medical Center Netanya Israel 4244916
    106 Tel Aviv Sourasky Medical Center Tel Aviv Israel 6423906
    107 Carmel Hospital Haifa Ḥeifā Israel 3436212
    108 ASST-Monza -U.O Ematologia Adulti Monza (MB) -Settore E Piano 2 Italy 20900
    109 Azienda Ospedaliero Universitaria Pisana Pisa PI Italy 56126
    110 Irccs Crob Rionero In Vulture Potenza Italy 85028
    111 AULSS8 Berica-Ospedale S.Bortolo Vicenza Veneto Italy 36100
    112 Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo Alessandria Italy 15100
    113 Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo Italy 24127
    114 ASST Spedali Civili - Università degli Studi Brescia Italy 25123
    115 A.O.U. Policlinico G.Rodolico - S. Marco Catania Italy 95123
    116 Azienda Ospedaliera Pugliese Ciaccio Catanzaro Italy 88100
    117 Azienda Ospedaliera Universitaria Careggi Firenze Italy 50134
    118 IRCCS Ospedale Policlinico San Martino Genova Italy 16132
    119 Ospedale Papardo Messina Italy 98158
    120 IRCCS Ospedale San Raffaele Milano Italy 20132
    121 ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C Milano Italy 20162
    122 A.O.U. di Modena Modena Italy 41224
    123 Fondazione IRCCS Policlinico San Matteo Pavia Italy 27100
    124 Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich) Perugia Italy 06132
    125 Ospedale Santa Maria delle Croci Ravenna Italy 48020
    126 Fondazione Policlinico Universitario Agostino Gemelli Roma Italy 00168
    127 Azienda Ospedaliera Santa Maria Terni Terni Italy 05100
    128 A.O.U. Citta' della Salute e della Scienza di Torino Torino Italy 10126
    129 Az. Osp. "Card G Panico" Tricase Italy 4 - 73039
    130 Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy 34125
    131 Ospedale Policlinico Giambattista Rossi, Borgo Roma Verona Italy 37134
    132 Nagoya Medical Center Nagoya Aichi Japan 460-0001
    133 Aichi Cancer Center Hospital Nagoya Aichi Japan 464-8681
    134 Nagoya City University Hospital Nagoya Aichi Japan 467-8602
    135 Ogaki Municipal Hospital Ogaki-shi Gifu Japan 503-8502
    136 Hokkaido University Hospital Sapporo Hokkaido Japan 060-8648
    137 Kobe City Medical Center General Hospital Kobe Hyogo Japan 650-0047
    138 Tokai University Hospital- Isehara Campus Isehara Kanagawa Japan 259-1143
    139 Kochi Medical School Hospital Nankoku Kochi Japan 783-8505
    140 Tohoku University Hospital Sendai-shi Miyagi Japan 980-8574
    141 Kindai University Hospital Osaka Sayama-shi Osaka Japan 589 8511
    142 Saitama Medical Center Kawagoe Saitama Japan 350-8550
    143 Japanese Foundation for Cancer Research Koto Tokyo Japan 135-8550
    144 NTT Medical Center Tokyo Shinagawa-Ku Tokyo Japan 141-8625
    145 Kumamoto University Hospital Kumamoto Japan 860-8556
    146 Okayama University Hospital Okayama Japan 700-8558
    147 Osaka University Hospital Osaka Japan 565-0871
    148 Gachon University Gil Hospital Namdong-gu Incheon-gwangyeoksi [Incheon] Korea, Republic of 21565
    149 Pusan National University Hospital Busan Pusan-Kwangyǒkshi Korea, Republic of 49241
    150 Seoul National University Hospital Seoul Seoul, Korea Korea, Republic of 03080
    151 Severance Hospital, Yonsei University Health System Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 03722
    152 The Catholic University of Korea-Seoul St. Mary's Hospital Seocho-Gu Seoul Korea, Republic of 06591
    153 Inje Univ Busan Paik Hospital Busan Korea, Republic of 47392
    154 Samsung Medical Center Seoul Korea, Republic of 06351
    155 Wojewodzki Szpital Specjalistyczny Iwaszkiewicza 5 Legnica Poland 59-220
    156 Centrum Onkologii Ziemi Lubelskiej Lublin Lubelskie Poland 20-081
    157 Uniwersyteckie Centrum Kliniczne Gdansk Pomorskie Poland 80-214
    158 Szpitale Pomorskie Sp. z o. o. Gdynia Pomorskie Poland 81-519
    159 Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza, Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej Brzozów Poland 36-200
    160 Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii Bydgoszcz Poland 85-168
    161 Pratia Onkologia Katowice Katowice Poland 40519
    162 Pratia MCM Krakow Krakow Poland 30-510
    163 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Warszawa Poland 02-781
    164 Uniwersytecki Szpital Kliniczny Klinika Wrocław Poland 50-367
    165 Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii Łódź Poland 93510
    166 Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary" Omsk Omskaya Oblast' Russian Federation 644013
    167 Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency Saint Petersburg Russian Federation 191024
    168 Academician I.P. Pavlov First St-Petersburg State Medical University Saint Petersburg Russian Federation 197022
    169 Oncology Dispensary #2 of Krasnodar Region Sochi Russian Federation 354057
    170 Gleneagles Medical Centre Singapore Central Singapore Singapore 258499
    171 Hospital Duran I Reynals Hospitalet De Llobregat Barcelona Spain 08908
    172 Hospital Universitario de Toledo Toledo Castilla La Mancha Spain 45004
    173 Complejo Hospitalario Universitario de Santiago de Compostel Santiago de Compostela La Coruna Spain 15706
    174 Hospital Universitario Ramon y Cajal Madrid Madrid, Comunidad De Spain 28034
    175 Hospital Universitario Quironsalud Madrid Pozuelo De Alarcón Madrid Spain 28223
    176 Hospital General Universitario Gregorio Marañon Madrid Planta Baja Spain 28007
    177 Hospital General de Albacete Albacete Spain 02006
    178 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    179 Hospital Clinic de Barcelona Barcelona Spain 08036
    180 Hospital San Pedro de Alcántara Caceres Spain 10003
    181 Hospital Universitario Infanta Leonor-INTERNAL MED Madrid Spain 28031
    182 Hospital Universitario La Paz Madrid Spain 28046
    183 Hospital Universitario Marques De Valdecilla Santander Spain 39008
    184 Hospital Universitario Virgen del Rocío Sevilla Spain 41013
    185 Hospital Universitario de Alava Vitoria Spain 01005
    186 Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale Bellinzona Svizzera Switzerland 6500
    187 China Medical University Hospital Taichung City Taichung Taiwan 40447
    188 Tri-Service General Hospital Taipei City Taipei Taiwan 114
    189 Taipei Veterans General Hospital Taipei Taiwan 11217
    190 Chang Gung Memorial Hospital - Linkou Taoyuan, (r.o.c.) Taiwan 33342
    191 Aberdeen Royal Infirmary Aberdeen Aberdeen City United Kingdom AB25 2ZN
    192 The Royal Cornwall Hospital Truro Cornwall United Kingdom TR1 3LJ
    193 Derriford Hospital Plymouth Devon United Kingdom PL6 8DH
    194 Castle Hill Hospital Cottingham East Yorkshire United Kingdom HU16 5JQ
    195 University College London Hospitals London Greater London United Kingdom WC1E 6HX
    196 Norfolk and Norwich Hospital Norwich Norfolk United Kingdom NR4 7UY
    197 Singleton Hospital Swansea Sa2 8qa United Kingdom
    198 Western General Hospital Edinburgh Scotland United Kingdom EH4 2XU
    199 Royal Marsden Hospital Sutton Surrey United Kingdom SM2 5PT
    200 Milton Keynes University Hospital Milton Keynes United Kingdom MK6 5LD
    201 GenesisCare Cambridge Newmarket United Kingdom CB8 7XN

    Sponsors and Collaborators

    • Loxo Oncology, Inc.
    • Eli Lilly and Company

    Investigators

    • Study Director: Marisa Hill, MD, Loxo Oncology, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Loxo Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT04666038
    Other Study ID Numbers:
    • LOXO-BTK-20020
    • J2N-OX-JZNN
    First Posted:
    Dec 14, 2020
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Loxo Oncology, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2022