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A Study of LY3405105 in Participants With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT03770494
Recruitment Status : Not yet recruiting
First Posted : December 10, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to investigate the safety of LY3405105 in participants with advanced cancer. The study has two parts (A and B). Participants will only enroll in one part.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: LY3405105 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 215 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors
Estimated Study Start Date : January 14, 2019
Estimated Primary Completion Date : May 5, 2022
Estimated Study Completion Date : May 5, 2022

Arm Intervention/treatment
Experimental: LY3405105
LY3405105 administered orally.
Drug: LY3405105
Administered orally.




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]
    Number of participants with DLTs


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3405105 [ Time Frame: Predose Lead in Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles) ]
    PK: AUC of LY3405105

  2. Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months) ]
    ORR: Percentage of participants with a CR or PR

  3. Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months) ]
    DCR: Percentage of participants who exhibit SD, CR or PR

  4. Duration of Response (DOR) [ Time Frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) ]
    DOR

  5. Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 6 Months) ]
    TTR

  6. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) ]
    PFS

  7. Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Estimated up to 12 Months) ]
    OS



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have histological or cytological evidence of a diagnosis of a solid tumor cancer that is advanced and/or metastatic
  • Have available archived tissue for exploratory biomarker analysis
  • Have adequate organ function
  • Have discontinued all previous treatments for cancer and recovered from their side effects
  • Are able to swallow capsules/tablets

Exclusion Criteria:

  • Have symptomatic central nervous system (CNS) malignancy or metastasis
  • Have symptomatic human immunodeficiency virus (HIV), Hepatitis A, B, or C
  • Have congestive heart failure
  • Are breastfeeding
  • Have had a prior treatment with any cyclin-dependent kinase (CDK) 7 inhibitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770494


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
United States, Connecticut
Yale University School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06520-8020
Contact    203-785-3333      
Principal Investigator: Patricia M LoRusso         
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Principal Investigator: Gary K Schwartz         
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact    646-888-5294      
Principal Investigator: Alison Schram         
Canada, Ontario
Princess Margaret Hospital Not yet recruiting
Toronto, Ontario, Canada, M5TY 2M9
Contact    4169464534      
Principal Investigator: Phillippe Bedard         
Spain
Hospital Universitari Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08035
Contact    34934894374      
Principal Investigator: Elena Garralda Cabanas         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03770494     History of Changes
Other Study ID Numbers: 17125
J1F-MC-JZFA ( Other Identifier: Eli Lilly and Company )
2018-002668-23 ( EudraCT Number )
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 11, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No