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Last Updated: May 28, 2020

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CLINICAL TRIALS PROFILE FOR LY2606368


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Clinical Trials for LY2606368

Trial ID Title Status Sponsor Phase Summary
NCT01115790 A Phase 1 Study in Participants With Advanced Cancer Completed Eli Lilly and Company Phase 1 The primary purpose of Parts A and B of this study is to evaluate the safety and toxicity of prexasertib (an inhibitor of checkpoint kinase 1[chk 1]) in participants with advanced or metastatic cancer (Part A), or squamous cell cancer of the head and neck or squamous cell cancer of any tumor type (Part B). Part C of the study will evaluate prexasertib in three different groups of participants; those with squamous cell cancer of the head and neck that has recurred or spread to other parts of the body, those with squamous non-small cell lung cancer that has recurred or spread, and those with squamous cell cancer of the anus that is not curable by existing therapy.
NCT02124148 A Study of Prexasertib (LY2606368) With Chemotherapy or Targeted Agents in Participants With Advanced Cancer Recruiting Eli Lilly and Company Phase 1 The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin, cetuximab, pemetrexed, fluorouracil or LY3023414) in participants with advanced cancer or cancer that has spread to another part of the body. The study has multiple parts (A, B, C, D and E). Participants will only enroll in one part.
NCT02203513 A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Triple Negative Breast Cancer, High Grade Serous Ovarian Cancer, and Metastatic Castrate-Resistant Prostate Cancer Recruiting National Cancer Institute (NCI) Phase 2 Background: - All cells go through cycles which allow them to divide. In normal cells, Chk1 and Chk2 (Chk1/2) stop cell division at various points to allow any damage to DNA to be repaired. - When Chk1/2 are not present, cells stop dividing and eventually die. LY2606368 blocks the Chk1/2 proteins. - Researchers hope that by blocking Chk1/2, it will cause tumor cells to die, thereby shrinking tumors. Objective: - To see if LY2606368 helps shrink tumors in patients with certain breast, ovarian or prostate cancers. Eligibility: - Patients at least 18 years old with breast or ovarian cancer. They must have a mutation in BRCA1/2 genes for group 1, high grade serious ovarian cancer without BRCA1/2 mutation for group 2, or triple negative breast cancer without BRCA1/2 mutation for group 3, or prostate cancer with or without BRCA1/2 mutation for group 4. Design: - Participants will be screened with a medical history and physical exam. They will have blood tests, an electrocardiogram (ECG) heart test, scans, and X-rays. They will have a piece of their tumor removed at entry (CT-assisted biopsy). - Study Day 1: Participants will have a physical exam and blood drawn. They may have a CT scan of the chest, abdomen, and pelvis. - Day 1 and Day 15 of each 28-day cycle: Participants will receive the study drug through an IV. - Vital signs will be checked before and after. An ECG will be done within 1 hour after. - Day 15 and Day 28: Participants will have a physical exam, blood drawn, and a 12 lead ECG. - Cycle 1: Participants will have weekly phone calls and blood draws. Participants may have another CT-assisted biopsy at the end of cycle 1. - Cycle 2 and beyond, blood will be drawn every other week for routine blood tests. - Participants will have an after-study visit with a physical exam and blood tests. Participants may have another biopsy when they progressed on treatment. They will have scans of the chest, pelvis, and abdomen and a 12 lead ECG.
NCT02514603 A Study of Prexasertib (LY2606368) in Japanese Participants With Advanced Cancers Recruiting Eli Lilly and Company Phase 1 The primary purpose of this study is to assess the tolerability of prexasertib in Japanese participants with advanced solid cancers.
NCT02555644 A Study of Prexasertib (LY2606368) With Chemotherapy and Radiation in Participants With Head and Neck Cancer Recruiting Eli Lilly and Company Phase 1 The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. The study has two parts (A and B). Participants will only enroll in one part. Participants in the United States may enroll in either Part A or Part B. Participants in France may only be enrolled in Part A.
NCT02649764 LY2606368 in Combination With Cytarabine and Fludarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (HRMDS) Recruiting Eli Lilly and Company Phase 1 The goal of this clinical research study is to study the safety of LY2606368 when given in combination with fludarabine and cytarabine. The effectiveness of the study drug combination when given to patients with relapsed or refractory AML or HRMDS will also be studied.
NCT02649764 LY2606368 in Combination With Cytarabine and Fludarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (HRMDS) Recruiting M.D. Anderson Cancer Center Phase 1 The goal of this clinical research study is to study the safety of LY2606368 when given in combination with fludarabine and cytarabine. The effectiveness of the study drug combination when given to patients with relapsed or refractory AML or HRMDS will also be studied.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for LY2606368

Condition Name

Condition Name for
Intervention Trials
Advanced Cancer 3
Ovarian Cancer 2
Medulloblastoma, Non-WNT/Non-SHH, Group 4 1
Carcinoma, Squamous Cell of Head and Neck 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Neoplasms 5
Leukemia, Myeloid, Acute 2
Neoplasm Metastasis 2
Leukemia, Myeloid 2
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Clinical Trial Locations for LY2606368

Trials by Country

Trials by Country for
Location Trials
United States 44
United Kingdom 8
Italy 4
Australia 4
Spain 3
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Trials by US State

Trials by US State for
Location Trials
Massachusetts 6
Tennessee 6
Texas 5
Florida 5
Oklahoma 3
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Clinical Trial Progress for LY2606368

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 4
Phase 1 12
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 13
Not yet recruiting 2
Completed 1
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Clinical Trial Sponsors for LY2606368

Sponsor Name

Sponsor Name for
Sponsor Trials
Eli Lilly and Company 13
Dana-Farber Cancer Institute 3
National Cancer Institute (NCI) 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 14
Other 7
NIH 1
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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Mallinckrodt
McKesson
AstraZeneca
Moodys

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