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

Brief Title

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

Official Title

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

Brief Summary

      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 Phase

Phase 1

Study Type

Interventional

Primary Outcome

Maximum Tolerated Dose (MTD) of LY3039478

Secondary Outcome

 Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve (AUC) of LY3039478 in Combination with Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin

Condition

Solid Tumor

Intervention

LY3039478

Study Arms / Comparison Groups

 LY3039478 + Taladegib

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

94

Start Date

November 4, 2016

Completion Date

February 13, 2020

Primary Completion Date

August 9, 2018

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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), , 

Location Countries

Denmark

Location Countries

Denmark

NCT ID

NCT02784795

Organization ID

16209

Secondary IDs

I6F-MC-JJCD

Responsible Party

Sponsor

Study Sponsor

Eli Lilly and Company

Study Sponsor

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), Study Director, Eli Lilly and Company

Verification Date

August 2020