Abemaciclib

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Information
Drug Name
Abemaciclib
Description
Entry(CIViC)
2
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
lung non-small cell carcinoma KRAS MUTATION KRAS MUTATION B Predictive Supports Sensitivity/Response Somatic 3 27217383 Detail
lung non-small cell carcinoma KRAS p.Ala146Val (p.A146V)
( ENST00000311936.8, ENST00000557334.6, ENST00000256078.10, ENST00000685328.1, ENST00000688940.1, ENST00000692768.1, ENST00000693229.1 ) KRAS p.Ala146Val (p.A146V)
( ENST00000256078.10, ENST00000311936.8, ENST00000557334.6, ENST00000685328.1, ENST00000688940.1, ENST00000692768.1, ENST00000693229.1 )
C Predictive Supports Sensitivity/Response Somatic 2 24836576 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
In this multicenter phase I study of abemaciclib, ... KRAS KRAS MUTATION KRAS MUTATION Sensitivity true CIViC Evidence detail
Case report of a patient with metastatic lung aden... KRAS KRAS p.Ala146Val (p.A146V)
( ENST00000311936.8, ENST00000557334.6, ENST00000256078.10, ENST00000685328.1, ENST00000688940.1, ENST00000692768.1, ENST00000693229.1 ) KRAS p.Ala146Val (p.A146V)
( ENST00000256078.10, ENST00000311936.8, ENST00000557334.6, ENST00000685328.1, ENST00000688940.1, ENST00000692768.1, ENST00000693229.1 )
Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT02107703 Active, not recruiting Phase 3 A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer July 22, 2014 December 30, 2024
NCT02747004 Active, not recruiting Phase 2 A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer September 14, 2016 December 30, 2024
NCT04238819 Active, not recruiting Phase 1/Phase 2 A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma November 9, 2020 October 2028
NCT04616183 Active, not recruiting Phase 1/Phase 2 LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer December 2, 2020 December 31, 2025
NCT03531645 Active, not recruiting Phase 2 Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma August 13, 2019 September 30, 2024
NCT03643510 Active, not recruiting Phase 2 Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer August 21, 2018 August 2026
NCT03654833 Active, not recruiting Phase 2 Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma January 28, 2019 October 31, 2023
NCT04227327 Active, not recruiting Phase 2 Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7) January 7, 2020 December 2023
NCT02152631 Active, not recruiting Phase 3 A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer October 3, 2014 December 31, 2024
NCT04627064 Active, not recruiting Phase 1 ABEMA Alone or in COMBO With MK-6482 December 31, 2020 December 31, 2025
NCT03706365 Active, not recruiting Phase 2/Phase 3 A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer November 26, 2018 June 2026
NCT04481113 Active, not recruiting Phase 1 Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer June 7, 2021 December 30, 2025
NCT04603183 Active, not recruiting Phase 2 ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL June 2, 2021 June 30, 2025
NCT04188548 Active, not recruiting Phase 1 A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer December 10, 2019 December 2027
NCT02246621 Active, not recruiting Phase 3 A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer November 6, 2014 December 16, 2024
NCT05169567 Active, not recruiting Phase 3 Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer March 11, 2022 February 16, 2026
NCT05999968 Active, not recruiting Phase 1 Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment January 12, 2024 July 2026
NCT02763566 Active, not recruiting Phase 3 A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer December 5, 2016 December 31, 2024
NCT03905889 Active, not recruiting Phase 1 A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma June 5, 2019 November 5, 2024
NCT03939897 Active, not recruiting Phase 1/Phase 2 Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer June 17, 2020 March 11, 2025
NCT02779751 Active, not recruiting Phase 1 A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer November 14, 2016 December 31, 2024
NCT05288166 Active, not recruiting Phase 3 A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) April 14, 2022 October 2027
NCT04931342 Active, not recruiting Phase 2 A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors October 7, 2021 December 31, 2028
NCT02791334 Active, not recruiting Phase 1 A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors June 29, 2016 July 2024
NCT05759949 Active, not recruiting Phase 1 First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors March 29, 2023 July 25, 2024
NCT04393285 Active, not recruiting Phase 2 Abemaciclib and Letrozole to Treat Endometrial Cancer October 10, 2020 December 1, 2025
NCT05617885 Active, not recruiting Phase 1/Phase 2 Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer August 9, 2023 June 1, 2026
NCT02846987 Active, not recruiting Phase 2 Study of Abemaciclib in Dedifferentiated Liposarcoma July 2016 July 2024
NCT04074785 Active, not recruiting Early Phase 1 Abemaciclib w/Bevacizumab in Recurrent GBM Pts w/Loss of CDKN2A/B or Gain or Amplification of CDK4/6 December 13, 2019 October 24, 2025
NCT04752332 Active, not recruiting Phase 3 A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer May 10, 2021 June 30, 2024
NCT04751929 Active, not recruiting Phase 2 Abemaciclib With or Without Atezolizumab for mCRPC August 20, 2021 December 20, 2025
NCT04545710 Active, not recruiting Phase 2 Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance November 21, 2020 December 1, 2023
NCT04552769 Active, not recruiting Phase 2 Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer September 10, 2020 December 2024
NCT04352777 Active, not recruiting Phase 2 Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer September 14, 2020 December 30, 2024
NCT02981940 Active, not recruiting Phase 2 A Study of Abemaciclib in Recurrent Glioblastoma February 9, 2017 June 2025
NCT03099174 Active, not recruiting Phase 1 This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer. May 4, 2017 May 30, 2024
NCT04293393 Active, not recruiting Phase 2 Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients October 2, 2020 February 28, 2033
NCT03155997 Active, not recruiting Phase 3 Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer July 12, 2017 May 28, 2029
NCT03220646 Active, not recruiting Phase 2 Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors July 13, 2017 July 2024
NCT03280563 Active, not recruiting Phase 1/Phase 2 A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer December 26, 2017 December 31, 2024
NCT03284957 Active, not recruiting Phase 1/Phase 2 Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer September 20, 2017 December 29, 2027
NCT02792725 Approved for marketing Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
NCT03763604 Available Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
NCT02450539 Completed Phase 2 A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer August 6, 2015 July 29, 2020
NCT02644460 Completed Phase 1 Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors February 2016 October 10, 2023
NCT02675231 Completed Phase 2 A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer May 23, 2016 November 9, 2023
NCT04408924 Completed Phase 2 Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer January 20, 2021 June 2, 2023
NCT02677844 Completed Phase 1 A Study of Abemaciclib in Healthy Participants February 2016 July 2016
NCT02688088 Completed Phase 1 A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body March 8, 2016 January 6, 2021
NCT04514159 Completed Phase 1 A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer November 12, 2020 October 24, 2022
NCT02079636 Completed Phase 1 A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC) March 28, 2014 August 29, 2019
NCT02745769 Completed Phase 1 A Study in Advanced Cancers Using Ramucirumab (LY3009806) and Other Targeted Agents October 21, 2016 January 22, 2019
NCT04707196 Completed Phase 4 A Study of Abemaciclib in Indian Women With Advanced Breast Cancer February 22, 2021 January 9, 2023
NCT02784795 Completed Phase 1 A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors November 4, 2016 February 13, 2020
NCT02831530 Completed Phase 2 Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients March 16, 2016 February 2, 2018
NCT02857270 Completed Phase 1 A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer September 29, 2016 October 24, 2022
NCT02884089 Completed Phase 1 A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants August 2016 December 2016
NCT02919696 Completed Phase 1 A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers August 7, 2017 September 3, 2019
NCT02102490 Completed Phase 2 A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread June 10, 2014 October 22, 2018
NCT02981342 Completed Phase 2 A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma January 12, 2017 November 9, 2018
NCT03292250 Completed Phase 2 Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)] September 10, 2017 March 10, 2022
NCT03339843 Completed Phase 2 Multiorgan Metabolic Imaging Response Assessment of Abemaciclib December 19, 2018 December 20, 2023
NCT03356223 Completed Phase 2 Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6 February 5, 2018 December 5, 2022
NCT02117648 Completed Phase 1 A Study of LY2835219 in Participants With Cancer April 2014 August 2015
NCT03703466 Completed Phase 2 A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer November 28, 2018 March 9, 2023
NCT02308020 Completed Phase 2 A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain April 20, 2015 November 8, 2019
NCT02387814 Completed Phase 1 A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment March 2015 August 2015
NCT02411591 Completed Phase 1 A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC) June 4, 2015 May 28, 2019
NCT05789771 Completed Abemaciclib for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia. April 1, 2022 December 1, 2022
NCT01655225 Completed Phase 1 A Study of LY3023414 in Participants With Advanced Cancer July 31, 2012 February 2, 2022
NCT02441946 Completed Phase 2 A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer August 2015 February 12, 2018
NCT04071262 Completed Phase 1 A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Therapies in Japanese Participants With Advanced Cancer December 20, 2019 August 30, 2021
NCT05141240 Completed A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors April 15, 2020 June 15, 2020
NCT02482935 Completed Phase 1 A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food June 2015 September 2015
NCT01739309 Completed Phase 2 Study of LY2835219 for Mantle Cell Lymphoma March 20, 2013 September 5, 2022
NCT05153135 Completed Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors May 8, 2020 July 31, 2020
NCT04256941 Completed Phase 2 Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study May 31, 2019 September 22, 2023
NCT06179303 Not yet recruiting Phase 2 Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer July 6, 2024 June 1, 2026
NCT06413706 Not yet recruiting Phase 2 A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy June 2024 February 2028
NCT05940493 Not yet recruiting Phase 2 Abemaciclib in Newly Diagnosed Meningioma Patients June 15, 2024 December 2031
NCT06366347 Not yet recruiting Phase 2 ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab September 2024 March 1, 2029
NCT06025747 Not yet recruiting Phase 1 Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma July 1, 2024 March 3, 2026
NCT06380751 Not yet recruiting Phase 3 Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer April 18, 2024 July 18, 2030
NCT05774899 Recruiting Phase 1/Phase 2 CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC June 1, 2023 June 1, 2026
NCT02523014 Recruiting Phase 2 Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas August 2015 October 2024
NCT02693535 Recruiting Phase 2 TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer March 14, 2016 December 31, 2025
NCT02925234 Recruiting Phase 2 The Drug Rediscovery Protocol (DRUP Trial) August 2016 December 2027
NCT03310879 Recruiting Phase 2 Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6 November 21, 2017 April 30, 2025
NCT03424005 Recruiting Phase 1/Phase 2 A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer April 2, 2018 May 3, 2026
NCT03675893 Recruiting Phase 2 RESOLVE: Abemaciclib + Letrozole +/- Metformin or Zotatifin in Endometrial or Low-Grade Serous Ovarian Cancer December 24, 2018 August 1, 2029
NCT03837821 Recruiting Early Phase 1 (CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer February 5, 2019 December 2025
NCT03891784 Recruiting Phase 2 Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors October 31, 2019 September 30, 2026
NCT03979508 Recruiting Phase 2 Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer January 10, 2020 July 31, 2024
NCT03994796 Recruiting Phase 2 Genetic Testing in Guiding Treatment for Patients With Brain Metastases August 15, 2019 June 2025
NCT04040205 Recruiting Phase 2 Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration October 7, 2019 June 1, 2027
NCT04092673 Recruiting Phase 1/Phase 2 Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies October 25, 2019 March 31, 2025
NCT04158362 Recruiting Phase 3 Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer June 11, 2020 June 2028
NCT04169074 Recruiting Phase 2 Immune Modulation by Abemaciclib in HNSCC. (AIM Trial) June 16, 2021 June 30, 2024
NCT04305834 Recruiting Phase 2 Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer. March 25, 2020 August 21, 2024
NCT04391595 Recruiting Early Phase 1 LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients July 8, 2020 February 2025
NCT04469764 Recruiting Phase 2 Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer October 16, 2020 July 1, 2026
NCT04486352 Recruiting Phase 1/Phase 2 A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer October 20, 2021 October 2026
NCT04523857 Recruiting Phase 2 ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer November 1, 2021 December 2028
NCT04584853 Recruiting Phase 3 PreOperative Endocrine Therapy for Individualised Care With Abemaciclib December 23, 2020 March 31, 2032
NCT04614194 Recruiting Phase 2 Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib April 15, 2021 April 15, 2028
NCT04633239 Recruiting Phase 1 Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer July 2, 2021 December 1, 2024
NCT04681768 Recruiting Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients December 22, 2020 December 2024
NCT05464173 Recruiting Phase 1/Phase 2 Chidamide in Combination With Abemaciclib and Endocrinotherapy(Doctor's Choice) in Breast Cancer Patients Previously Treated With Palbociclib July 1, 2022 May 1, 2025
NCT05501704 Recruiting Phase 2 ETHAN - ET for Male BC October 11, 2023 April 1, 2036
NCT05524584 Recruiting Phase 2 Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer August 31, 2022 December 31, 2028
NCT05548127 Recruiting Phase 1/Phase 2 TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) February 23, 2023 December 31, 2025
NCT05563220 Recruiting Phase 1/Phase 2 Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer January 24, 2023 August 31, 2026
NCT05608252 Recruiting Phase 1/Phase 2 VS-6766+Abema+Fulv in Met HR+/HER- BC February 23, 2023 December 31, 2028
NCT05708235 Recruiting Phase 2 A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population April 1, 2024 December 30, 2028
NCT05714072 Recruiting Phase 1 A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis January 25, 2023 January 2025
NCT05766410 Recruiting Phase 2 A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC September 16, 2022 September 30, 2026
NCT05867251 Recruiting Phase 1/Phase 2 Study of AVZO-021 in Patients With Advanced Solid Tumors August 30, 2023 January 31, 2030
NCT05872204 Recruiting Phase 2 Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer November 30, 2023 October 2026
NCT05891093 Recruiting Phase 3 Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01) June 1, 2023 May 31, 2031
NCT05933395 Recruiting Phase 2 Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor October 10, 2023 October 2031
NCT05952557 Recruiting Phase 3 An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) October 5, 2023 May 6, 2037
NCT05999994 Recruiting Phase 2 A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer January 22, 2020 May 1, 2026
NCT06001762 Recruiting Phase 2 TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer October 5, 2023 January 1, 2027
NCT06065748 Recruiting Phase 3 A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) December 11, 2023 December 30, 2028
NCT06139107 Recruiting Phase 1 RADIANT: Pre-op Radiation With Abemaciclib and Letrozole June 21, 2024 September 30, 2032
NCT06169371 Recruiting Phase 4 Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI) December 28, 2023 November 2030
NCT06188520 Recruiting Phase 1/Phase 2 A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors December 5, 2023 June 18, 2025
NCT06365788 Recruiting Phase 2 Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer April 8, 2024 December 2027
NCT06409390 Recruiting Early Phase 1 Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer April 26, 2024 April 2027
NCT04750928 Recruiting Phase 1/Phase 2 Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas November 29, 2021 December 1, 2026
NCT04791384 Recruiting Phase 1/Phase 2 Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer April 21, 2022 January 2025
NCT04802759 Recruiting Phase 1/Phase 2 A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer June 20, 2021 October 31, 2026
NCT04862663 Recruiting Phase 3 Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) May 10, 2021 August 14, 2029
NCT04923542 Recruiting Phase 1/Phase 2 Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases November 30, 2021 December 31, 2024
NCT04941274 Recruiting Phase 1/Phase 2 Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma September 29, 2021 June 1, 2028
NCT04961996 Recruiting Phase 3 A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) August 27, 2021 November 21, 2033
NCT04964934 Recruiting Phase 3 Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) June 30, 2021 November 26, 2027
NCT04967521 Recruiting Phase 3 SARC041: Study of Abemaciclib Versus Placebo in Patients With Advanced Dedifferentiated Liposarcoma November 11, 2021 November 2024
NCT04975308 Recruiting Phase 3 A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer October 4, 2021 August 31, 2027
NCT05095207 Recruiting Phase 1/Phase 2 Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer September 20, 2021 October 2026
NCT05113537 Recruiting Phase 1/Phase 2 Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer July 8, 2022 July 31, 2027
NCT05159245 Recruiting Phase 2 The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs December 10, 2021 November 25, 2026
NCT05307705 Recruiting Phase 1 A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors May 11, 2022 May 2025
NCT05372640 Recruiting Phase 1 Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors August 10, 2023 June 1, 2025
NCT05386108 Recruiting Phase 1/Phase 2 Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/HER2- Breast Cancer August 31, 2022 December 2025
NCT05440786 Recruiting Phase 2 CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma September 20, 2022 September 10, 2028
NCT03655444 Terminated Phase 1/Phase 2 Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy May 29, 2019 August 24, 2020
NCT03781960 Terminated Phase 2 Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma July 31, 2019 April 29, 2022
NCT04801966 Terminated N/A Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study September 23, 2021 December 30, 2022
NCT04534283 Terminated Phase 2 A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib. October 5, 2020 August 7, 2023
NCT03878524 Terminated Phase 1 Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial April 1, 2020 December 10, 2020
NCT04003896 Terminated Phase 2 A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma September 24, 2021 August 15, 2023
NCT03997448 Terminated Phase 2 Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149 August 26, 2019 January 30, 2020
NCT04305236 Terminated Phase 2 Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer July 23, 2020 February 16, 2022
NCT04165031 Terminated Phase 1/Phase 2 A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation November 28, 2019 October 30, 2020
NCT03130439 Terminated Phase 2 Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer May 26, 2017 January 30, 2022
NCT04031885 Terminated Phase 4 A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer August 14, 2019 August 11, 2020
NCT03356587 Unknown status Phase 2 A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy October 16, 2017 December 31, 2020
NCT04852081 Unknown status Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study. January 1, 2021 December 1, 2021
NCT04921904 Unknown status Phase 1/Phase 2 Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca June 2021 June 2024
NCT04049227 Unknown status Early Phase 1 Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer August 12, 2019 July 1, 2023
NCT04316169 Withdrawn Phase 1 Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer October 21, 2021 January 2028
NCT04351230 Withdrawn Phase 2 T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer November 11, 2020 February 16, 2022
NCT04118036 Withdrawn Phase 2 Abemaciclib + Pembrolizumab In Glioblastoma December 1, 2021 December 1, 2024
NCT03988114 Withdrawn Phase 4 A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer September 16, 2019 March 23, 2023
NCT04585724 Withdrawn Phase 1 Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases June 12, 2020 September 13, 2021
NCT03846583 Withdrawn Phase 1 Tucatinib + Abemaciclib + Herceptin for HER2+ MBC June 28, 2020 September 22, 2020
NCT04220892 Withdrawn Early Phase 1 Pilot Study of Pembrolizumab Combined With Pemetrexed or Abemaciclib for High Grade Glioma July 8, 2020 July 8, 2020