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Last Updated: May 16, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR VERZENIO

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All Clinical Trials for Verzenio

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03655444 Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy Not yet recruiting Eli Lilly and Company Phase 1/Phase 2 2018-12-31 In phase I of the trial, the investigators aim to explore the safety and feasibility of abemaciclib in combination with nivolumab in patients with recurrent/metatstatic head and neck squamous cell carcinoma (RM-HNSCC). A dose de-escalation study design will be used to determine the recommended phase II dose (RP2D) of abemaciclib given with the standard dose of nivolumab. In phase II of the trial, the investigators aim to determine if abemaciclib and nivolumab will improve the one year survival from 36% (historical comparison with nivolumab) to 60% (abemaciclib + nivolumab) in patients with RM-HNSCC that had progressed or recurred within six months after platinum-based chemotherapy. Patients will be treated with abemaciclib at the recommended phase 2 dose (RP2D) in combination with standard doses of nivolumab. If this aim is met, genome sequencing, bulk and single cell RNAseq, and selected protein expression and deep cellular phenotyping will be performed on tumor tissue and blood obtained before and during treatment with abemaciclib and nivolumab. These biomarker data will be correlated with survival and tumor response to abemaciclib and nivolumab.
NCT03655444 Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy Not yet recruiting Washington University School of Medicine Phase 1/Phase 2 2018-12-31 In phase I of the trial, the investigators aim to explore the safety and feasibility of abemaciclib in combination with nivolumab in patients with recurrent/metatstatic head and neck squamous cell carcinoma (RM-HNSCC). A dose de-escalation study design will be used to determine the recommended phase II dose (RP2D) of abemaciclib given with the standard dose of nivolumab. In phase II of the trial, the investigators aim to determine if abemaciclib and nivolumab will improve the one year survival from 36% (historical comparison with nivolumab) to 60% (abemaciclib + nivolumab) in patients with RM-HNSCC that had progressed or recurred within six months after platinum-based chemotherapy. Patients will be treated with abemaciclib at the recommended phase 2 dose (RP2D) in combination with standard doses of nivolumab. If this aim is met, genome sequencing, bulk and single cell RNAseq, and selected protein expression and deep cellular phenotyping will be performed on tumor tissue and blood obtained before and during treatment with abemaciclib and nivolumab. These biomarker data will be correlated with survival and tumor response to abemaciclib and nivolumab.
NCT03675893 A Phase 2 Study of LY3023414 and Abemaciclib With or Without Letrozole in Endometrial Cancer Recruiting Eli Lilly and Company Phase 2 2018-12-24 This research study is studying a combination of targeted therapies as a possible treatment for endometrial cancer. The drugs involved in this study are: - Abemaciclib (also known as Verzenio™) - LY3023414 - Letrozole (also known as Femara®)
NCT03675893 A Phase 2 Study of LY3023414 and Abemaciclib With or Without Letrozole in Endometrial Cancer Recruiting Dana-Farber Cancer Institute Phase 2 2018-12-24 This research study is studying a combination of targeted therapies as a possible treatment for endometrial cancer. The drugs involved in this study are: - Abemaciclib (also known as Verzenio™) - LY3023414 - Letrozole (also known as Femara®)
NCT03846583 Tucatinib + Abemaciclib + Herceptin for HER2+ MBC Not yet recruiting Eli Lilly and Company Phase 1 2019-02-28 This research study is studying a combination of drugs as a possible treatment for HER2-Postive Metastatic Breast Cancer. The interventions involved in this study are: - Tucatinib - Abemaciclib (VerzenioTM) - Trastuzumab (Herceptin®) - Endocrine Therapy: Exemestane (Aromasin®), Letrozole (Femara®), or Anastrozole (Arimidex®)
NCT03846583 Tucatinib + Abemaciclib + Herceptin for HER2+ MBC Not yet recruiting Dana-Farber Cancer Institute Phase 1 2019-02-28 This research study is studying a combination of drugs as a possible treatment for HER2-Postive Metastatic Breast Cancer. The interventions involved in this study are: - Tucatinib - Abemaciclib (VerzenioTM) - Trastuzumab (Herceptin®) - Endocrine Therapy: Exemestane (Aromasin®), Letrozole (Femara®), or Anastrozole (Arimidex®)
NCT03891784 Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors Not yet recruiting National Cancer Institute (NCI) Phase 2 2019-05-04 This phase II trial studies how well abemaciclib works in treating patients with digestive system neuroendocrine tumors that have spread to other places in the body, do not respond to treatment, and cannot be removed by surgery. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Verzenio

Condition Name

Condition Name for Verzenio
Intervention Trials
Prognostic Stage IV Breast Cancer AJCC v8 5
Metastatic Breast Carcinoma 5
Anatomic Stage IV Breast Cancer AJCC v8 5
Breast Cancer 3
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Condition MeSH

Condition MeSH for Verzenio
Intervention Trials
Carcinoma 11
Breast Neoplasms 11
Endometrial Neoplasms 2
Adenocarcinoma 2
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Clinical Trial Locations for Verzenio

Trials by Country

Trials by Country for Verzenio
Location Trials
United States 31
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Trials by US State

Trials by US State for Verzenio
Location Trials
Massachusetts 5
California 4
Arizona 2
Texas 2
Illinois 2
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Clinical Trial Progress for Verzenio

Clinical Trial Phase

Clinical Trial Phase for Verzenio
Clinical Trial Phase Trials
Phase 2 13
Phase 1/Phase 2 3
Phase 1 8
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Clinical Trial Status

Clinical Trial Status for Verzenio
Clinical Trial Phase Trials
Not yet recruiting 22
Recruiting 4
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Clinical Trial Sponsors for Verzenio

Sponsor Name

Sponsor Name for Verzenio
Sponsor Trials
National Cancer Institute (NCI) 12
Eli Lilly and Company 8
Dana-Farber Cancer Institute 5
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Sponsor Type

Sponsor Type for Verzenio
Sponsor Trials
Other 24
NIH 12
Industry 10
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