Clinical Trial: NCT01695005 - My Cancer Genome

NCT01695005

Description:

The purpose of this study is to find a recommended dose level of LY3039478 that can safely be taken by participants with advanced cancer or cancer that has spread to other parts of the body, including but not limited to lymphoma. The study will also explore changes to various markers in blood cells and tissue. Finally, the study will help to document any tumor activity this drug may have.

Related Conditions:

Adenoid Cystic Carcinoma
B-Cell Neoplasm
Breast Carcinoma
Cholangiocarcinoma
Chronic Lymphocytic Leukemia
Hepatocellular Carcinoma
Leiomyosarcoma
Lymphoma
Malignant Solid Tumor
T-Cell and NK-Cell Neoplasm

Recruiting Status:

Completed

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT01695005

Trial Eligibility

Document

Title

Brief Title: A Study of LY3039478 in Participants With Advanced Cancer
Official Title: A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer

Clinical Trial IDs

ORG STUDY ID: 14547
SECONDARY ID: I6F-MC-JJCA
NCT ID: NCT01695005

Conditions

Neoplasms
Neoplasm Metastasis
Lymphoma

Interventions

Drug	Synonyms	Arms
LY3039478		Dose 1 LY3039478 + Prednisone
Prednisone		Dose 1 LY3039478 + Prednisone

Purpose

Detailed Description

      In Part A of this study, participants with advanced/metastatic cancer (including lymphoma)
      will receive increasing doses of LY3039478 to define the dose level for Part B, C, D and E.
      In Part B, C, D and E LY3039478 will be explored at a predefined fixed dose level.
      Participants in Part B and D must have a defined alteration in a certain molecular pathway.
      Enrollment of participants in Part B, C, D and E will start once Part A is completed. In Part
      F participants will receive increasing doses of LY3039478 in combination with prednisone to
      define the maximum tolerated dose level.

Trial Arms

Name	Type	Description	Interventions
LY3039478 - Dose Escalation	Experimental	Part A: LY3039478 administered orally three times per week (TIW) at escalating doses (2.5 milligrams [mg] to 100 mg) for two 28 day cycles. Participants receiving benefit may continue until disease progression	LY3039478
LY3039478 - Cohort Expansion	Experimental	Part B, C, D and E: LY3039478 administered orally three times per week (TIW) at a fixed dose determined in Part A for two 28 day cycles. Participants receiving benefit may continue until disease progression.	LY3039478
Dose 1 LY3039478 + Prednisone	Experimental	Part F1: LY3039478 administered orally TIW for 28 day cycles. Prednisone will be co-administered with LY3039478 for the first 2 weeks in cycle 1 only (28 day cycles). Participants receiving benefit may continue until disease progression.	LY3039478 Prednisone
Dose 2 LY3039478 + Prednisone	Experimental	Part F2: LY3039478 administered orally TIW (twice a week in cycle 1) for 28 day cycles. Prednisone will be co-administered with LY3039478 for the first 2 weeks in cycle 1 only. Participants receiving benefit may continue until disease progression.	LY3039478 Prednisone

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 (Part A): The participant must have histological or cytological
             evidence of cancer, either a solid tumor or a lymphoma, which is advanced or
             metastatic.

          -  For Part B: All participants must have a histological evidence of their advanced or
             metastatic cancer and prescreened alterations in a defined pathway.

          -  For Part C: All participants must have histological evidence of advanced or metastatic
             specific subtypes of soft tissue sarcoma.

          -  For Part D: All participants must have histological evidence of advanced or metastatic
             cancer and prescreened alterations in a defined pathway.

          -  Cohort 1: Participants must have triple negative breast cancer.

          -  Cohort 2: Participants must have hepatocellular carcinoma (HCC). These participants
             should have Child-Pugh stage A.

          -  Cohort 3: Participants must have cholangiocarcinoma.

          -  Cohort 4: Participants must have chronic lymphocytic leukemia.

          -  Cohort 5: Participants must have a mature T cell, B cell, or natural killer (NK) cell
             neoplasm.

          -  For Part E: Participants must have adenoid cystic carcinoma (ACC).

          -  For Part F dose confirmation: Participants must have leiomyosarcoma and prescreened
             alterations in a defined pathway.

          -  As defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the
             Revised Response Criteria for Malignant Lymphoma or the Response Assessment in Neuro
             Oncology (RANO) criteria for glioblastoma:

               -  For Dose Escalation (Part A): Have measurable or nonmeasurable disease.

               -  For Parts B, C, D, E and F: Have measurable disease or reliable biomarker
                  measure.

          -  For Parts B, C, D, E and F: Have available tumor tissue.

          -  Have adequate organ function.

          -  Have a performance status of less than or equal to 1 on the Eastern Cooperative
             Oncology Group (ECOG) scale and life expectancy of more than 12 weeks.

        Exclusion Criteria:

          -  Have symptomatic or non stable central nervous system (CNS) malignancy.

          -  Females who are pregnant or lactating.

          -  Have active bacterial, fungal, and/or known viral infection.

          -  Have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or
             diarrhea (acute or chronic).

          -  Participants with HCC that:

               -  Have known HCC with fibro-lamellar or mixed histology.

               -  Have presence of clinically relevant ascites.

               -  Have had a liver transplant.

               -  Have active or uncontrolled clinically serious hepatitis B virus or hepatitis C
                  virus infection.

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Part A and F: Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame:	Baseline to disease progression or participant discontinuation (estimated 8 -12 weeks)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Pharmacokinetics: Maximum Concentration (Cmax) of LY3039478
Time Frame:	Predose up to 30 hours post dose
Safety Issue:
Description:

Measure:	Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3039478
Time Frame:	Predose up to 30 hours post dose
Safety Issue:
Description:

Measure:	Part A: Number of Participants with Tumor Response
Time Frame:	Baseline to disease progression or participant discontinuation (estimated 8 -12 weeks)
Safety Issue:
Description:

Measure:	Part B, C, D, E and F: Duration of Response (DoR)
Time Frame:	Date of Complete Response or Partial Response to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 6 Months)
Safety Issue:
Description:

Measure:	Part B, C, D, E and F: Progression Free Survival (PFS)
Time Frame:	Baseline to Objective Progression or Death from Any Cause (Estimated up to 6 Months)
Safety Issue:
Description:

Measure:	Part B, C, D, E and F: Overall Survival (OS)
Time Frame:	Baseline to Date of Death from Any Cause (Estimated up to 14 Months)
Safety Issue:
Description:

Details

Phase:	Phase 1
Primary Purpose:	Interventional
Overall Status:	Completed
Lead Sponsor:	Eli Lilly and Company

Last Updated

August 7, 2018

Clinical Trials /

A Study of LY3039478 in Participants With Advanced Cancer