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A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02836600
Recruitment Status : Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: LY3039478 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY3039478 in Japanese Patients With Advanced Solid Tumors
Actual Study Start Date : September 9, 2016
Actual Primary Completion Date : July 5, 2019
Estimated Study Completion Date : November 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3039478
LY3039478 given orally TIW (3 times per week) in 28 day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or any other discontinuation criteria are met.
 Drug: LY3039478
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with LY3039478 Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 days) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles) ]
  2. PK: Area Under the Curve (AUC) of LY3039478 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles) ]
  3. Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Disease Progression or Death (estimated at up to 9 months) ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic.
  • In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate.
  • Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Adequate organ function, including hematologic, hepatic, and renal.
  • Estimated life expectancy of ≥12 weeks.

Exclusion Criteria:

  • Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively.
  • Have serious preexisting medical conditions.
  • Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea.
  • Have an active bacterial, fungal, and/or known viral infection.
  • Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results.
Contacts and Locations
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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): NCT02836600


Locations
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Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kashiwa, Chiba, Japan, 277 8577
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02836600    
Other Study ID Numbers: 16191
I6F-JE-JJCC ( Other Identifier: Eli Lilly and Company )
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 15, 2020
Keywords provided by Eli Lilly and Company:
notch inhibitor
Additional relevant MeSH terms:
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Neoplasms