A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors

August 13, 2020 updated by: Eli Lilly and Company

A Phase 1b Study of LY3039478 in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors

The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • København Ø
      • Copenhagen, København Ø, Denmark, 2100
        • Rigshospitalet
  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Lyon Cedex 08, France, 69373
        • Centre LEON BERARD
      • Villejuif Cedex, France, 94805
        • Gustave Roussy
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.

    • For dose escalation for all combinations: The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.
    • For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
    • For Part B dose confirmation: All participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
    • For Part C dose confirmation: All participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
    • For Part D dose confirmation: All participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease).
    • For Part E dose confirmation: All participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (TNBC) and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >2 lines of systemic treatment for advanced or metastatic TNBC.
  • Have adequate organ function.
  • Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Have discontinued all previous therapies for cancer.

Exclusion Criteria:

  • Have current acute leukemia.
  • Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3039478 + Taladegib
LY3039478 given orally 3 times per week (TIW) in combination with taladegib given orally daily on a 28 day cycle. A single dose of taladegib will also be given on day 1 during a 3-day lead-in period.
Drug: LY3039478
Administered orally
Drug: Taladegib
Administered orally
Other Names:
  • LY2940680
Experimental: LY3039478 + LY3023414
LY3039478 given orally TIW in combination with LY3023414 given orally every 12 hours on a 28-day cycle. A single dose of LY3023414 will also be given on day 1 during a 3-day lead-in period.
Drug: LY3039478
Administered orally
Drug: LY3023414
Administered orally
Experimental: LY3039478 + Abemaciclib
LY3039478 given orally TIW in combination with abemaciclib given orally every 12 hours on a 28-day cycle. A single dose of abemaciclib will also be given on day 1 during a 3-day lead-in period.
Drug: Abemaciclib
Administered orally
Other Names:
  • LY2835219
Drug: LY3039478
Administered orally
Experimental: LY3039478 + Cisplatin/Gemcitabine
LY3039478 given orally TIW in combination with cisplatin and gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.
Drug: Cisplatin
Administered IV
Drug: LY3039478
Administered orally
Drug: Gemcitabine
Administered IV
Experimental: LY3039478 + Gemcitabine/Carboplatin
LY3039478 given orally TIW in combination with gemcitabine and carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Drug: Carboplatin
Administered IV
Drug: LY3039478
Administered orally
Drug: Gemcitabine
Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD) of LY3039478
Time Frame: Cycle 1 (up to 28 Days)
Cycle 1 (up to 28 Days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve (AUC) of LY3039478 in Combination with Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin
Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
PK: AUC of Taladegib and its Active Metabolite LSN3185556, in Combination with LY3039478
Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
PK: AUC of LY3023414 in Combination with LY3039478
Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
PK: AUC of Abemaciclib and its Major Active Metabolites LSN2839567 and LSN3106726, in Combination with LY3039478
Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
Duration of Response (DoR)
Time Frame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression (Estimated up to 12 Months)
Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression (Estimated up to 12 Months)
Progression Free Survival (PFS)
Time Frame: Baseline to Objective Disease Progression or Death (Estimated up to 12 Months)
Baseline to Objective Disease Progression or Death (Estimated up to 12 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2016

Primary Completion (Actual)

August 9, 2018

Study Completion (Actual)

February 13, 2020

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

August 17, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16209
  • I6F-MC-JJCD (Other Identifier: Eli Lilly and Company)
  • 2015-004421-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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