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Clinical trials for Abemaciclib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    42 result(s) found for: Abemaciclib. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2016-004362-26 Sponsor Protocol Number: I3Y-MC-JPCF Start Date*: 2017-08-14
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High-Risk, Node-Positive, ...
    Medical condition: Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006199 Breast cancer stage I PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Trial now transitioned) HU (Trial now transitioned) GB (GB - no longer in EU/EEA) BE (Trial now transitioned) DK (Trial now transitioned) FI (Trial now transitioned) PL (Trial now transitioned) GR (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned) FR (Trial now transitioned) PT (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2016-002218-36 Sponsor Protocol Number: I3Y-MC-JPCJ Start Date*: 2017-01-17
    Sponsor Name:Eli Lilly and Company
    Full Title: An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination with Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients wi...
    Medical condition: Metastatic Pancreatic Ductal Adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10033599 Pancreatic adenocarcinoma metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) BE (Completed) GB (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000288-18 Sponsor Protocol Number: I3Y-MC-JPCG Start Date*: 2016-07-21
    Sponsor Name:Lilly S.A.
    Full Title: A Randomized, Open-Label, Phase 2 Study of Abemaciclib plus Tamoxifen or Abemaciclib Alone, in Women with Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
    Medical condition: Breast cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) AT (Completed) BE (Completed) DE (Completed) CZ (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-001853-28 Sponsor Protocol Number: I3Y-MC-JPCP Start Date*: 2018-10-31
    Sponsor Name:Lilly S.A.
    Full Title: An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability when Receiving Abemaciclib for Patients with Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Br...
    Medical condition: Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-000290-24 Sponsor Protocol Number: I3Y-MC-JPCY Start Date*: 2020-08-17
    Sponsor Name:Eli Lilly and Company
    Full Title: CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated with a Novel Hormonal Agent and Taxane-based Chemotherapy
    Medical condition: Metastatic Castration-Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076506 Castration-resistant prostate cancer LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-004276-21 Sponsor Protocol Number: I3Y-MC-JPCM Start Date*: 2019-01-02
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 2/3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone with or without Abemaciclib in Patients with Metastatic Castration-Resistant Prostate Cancer
    Medical condition: Metastatic Castration-Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Trial now transitioned) DE (Restarted) GB (Completed) NL (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003897-24 Sponsor Protocol Number: ICRCTSU/2019/10068 Start Date*: 2020-07-06
    Sponsor Name:The Institute of Cancer Research
    Full Title: PreOperative Endocrine Therapy for Individualised Care with Abemaciclib
    Medical condition: Non-metastatic operable invasive ER+ HER2- breast cancer in post-menopausal women
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-003400-24 Sponsor Protocol Number: I3Y-MC-JPBZ Start Date*: 2016-01-29
    Sponsor Name:Lilly S.A.
    Full Title: monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib plus Trastuzumab with or without Fulvestrant to Standard-of-Care Chemotherapy of Physic...
    Medical condition: Hormone receptor positive, HER2-positive advanced breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) GR (Completed) BE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-004537-25 Sponsor Protocol Number: ET16-116 Start Date*: 2017-11-06
    Sponsor Name:Centre Léon Bérard
    Full Title: An Phase II trial aiming to evaluate the clinical interest of ABEMACICLIB monotherapy in patients with locally advanced/metastatic head and neck cancer after failure of platinum and cetuximab or an...
    Medical condition: Patients with locally advanced/metastatic head and neck cancer after failure of platinum and cetuximab or anti-EGFR-based
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067821 Head and neck cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-005486-75 Sponsor Protocol Number: I3Y-MC-JPBY Start Date*: 2015-07-24
    Sponsor Name:Lilly S.A.
    Full Title: neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination with Anastrozole to those of Abemaciclib Monotherapy and Anastrozole Mo...
    Medical condition: Postmenopausal Women with Hormone Receptor Postive, HER2 Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10007050 Cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) AT (Completed) DE (Completed) NL (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002301-10 Sponsor Protocol Number: I3Y-MC-JPEF Start Date*: 2022-02-15
    Sponsor Name:Eli Lilly and Company
    Full Title: postMONARCH: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib plus Fulvestrant to Placebo plus Fulvestrant in Participants with HR+, HER2-, Advan...
    Medical condition: HR+, HER2-, Advanced or Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned) DK (Trial now transitioned) CZ (Trial now transitioned) ES (Ongoing) HU (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004734-11 Sponsor Protocol Number: J1S-MC-JP04 Start Date*: Information not available in EudraCT
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination with Irinotecan and Temozolomide in Participants with Relapsed or Refractory Ewing's Sarcoma
    Medical condition: Ewing's Sarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015560 Ewing's sarcoma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004010-28 Sponsor Protocol Number: I3Y-MC-JPBO Start Date*: 2015-03-10
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 2 Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma
    Medical condition: Brain tumors, Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) BE (Completed) FR (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000510-11 Sponsor Protocol Number: Hermione-7 Start Date*: 2019-10-31
    Sponsor Name:UNIVERSITÀ DEGLI STUDI MILANO BICOCCA
    Full Title: A Phase 2, open label, multicenter, single arm trial evaluating the activity and safety of Abemaciclib + Aromatase Inhibitors (AIs) after 1st-line treatment with High-Dose Fulvestrant in Hormone-Re...
    Medical condition: Advanced breast cancer Hormone-Receptor-Positive (HR+), Human-Epidermal-Growth-factor-negative (HER2-)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10006283 Breast neoplasm malignant female LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-001087-10 Sponsor Protocol Number: ELA-0121 Start Date*: 2022-11-21
    Sponsor Name:Stemline Therapeutics, Inc
    Full Title: An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative B...
    Medical condition: Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-005156-94 Sponsor Protocol Number: I3Y-MC-JPCE Start Date*: 2016-06-15
    Sponsor Name:Eli Lilly and Company
    Full Title: Protocol I3Y-MC-JPCE A Phase 1b Study of Abemaciclib in Combination with Pembrolizumab for Patients with Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer
    Medical condition: Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006202 Breast cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) ES (Completed) FR (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004035-24 Sponsor Protocol Number: I3Y-MC-JPCW Start Date*: 2021-04-26
    Sponsor Name:Eli Lilly and Company
    Full Title: eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node-Positive, HR+, HER2+ Early Brea...
    Medical condition: High-Risk, Node-Positive, HR+, HER2+ Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006199 Breast cancer stage I PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) DE (Completed) FI (Prematurely Ended) AT (Completed) HU (Completed) GR (Completed) IT (Completed) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-000546-17 Sponsor Protocol Number: D8534C00001 Start Date*: 2021-07-28
    Sponsor Name:AstraZeneca AB
    Full Title: SERENA-6: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor...
    Medical condition: Estrogen Receptor-Positive, HER-2 negative Advanced Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) BG (Trial now transitioned) PT (Trial now transitioned) AT (Trial now transitioned) SK (Trial now transitioned) NO (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001334-34 Sponsor Protocol Number: CA209-7A8 Start Date*: 2020-12-10
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Randomized, Non-comparative Neoadjuvant Phase II Study in Patients with ER+/HER2- Breast Cancer >= 2 cm with Safety Run-in, Assessing Nivolumab + Abemaciclib or Palbociclib + Anastrozole
    Medical condition: ER+/HER2- Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DE (Prematurely Ended) BE (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-005042-21 Sponsor Protocol Number: I4X-MC-JFCU Start Date*: 2015-04-21
    Sponsor Name:Eli Lilly and Company
    Full Title: A Single-Arm, Multicenter, Phase 1b Study with an Expansion Cohort to Evaluate Safety and Efficacy of Necitumumab in Combination with Abemaciclib in Treatment of Patients with Stage IV Non-Small Ce...
    Medical condition: Non Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed)
    Trial results: View results
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