A Study of LY3039478 in Participants With Advanced Cancer

Lymphoma Clinical Trial

Official title:

A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695005
• Other study ID #: 14547
• Secondary ID: I6F-MC-JJCA
• Status: Completed
• Phase: Phase 1
• Start date: October 2012
• Est. completion date: June 26, 2018

Study information

• Verified date: August 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: June 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• LY3039478
Administered orally
• Prednisone
Administered orally

Locations

Country	Name	City	State
Denmark	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.	Kobenhavn
France	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.	Paris
France	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.	Villejuif
Germany	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.	Tübingen
Spain	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.	Barcelona
United Kingdom	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.	London
United States	University of Michigan	Ann Arbor	Michigan
United States	Harvard Medical School	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of Miami School of Medicine	Miami	Florida
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Denmark,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A and F: Number of Participants with Dose Limiting Toxicities (DLTs)		Baseline to disease progression or participant discontinuation (estimated 8 -12 weeks)
Primary	Part B, C, D, E and F: Number of Participants with Tumor Response		Baseline to disease progression or participant discontinuation (estimated 8 -12 weeks)
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY3039478		Predose up to 30 hours post dose
Secondary	Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3039478		Predose up to 30 hours post dose
Secondary	Part A: Number of Participants with Tumor Response		Baseline to disease progression or participant discontinuation (estimated 8 -12 weeks)
Secondary	Part B, C, D, E and F: Duration of Response (DoR)		Date of Complete Response or Partial Response to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 6 Months)
Secondary	Part B, C, D, E and F: Progression Free Survival (PFS)		Baseline to Objective Progression or Death from Any Cause (Estimated up to 6 Months)
Secondary	Part B, C, D, E and F: Overall Survival (OS)		Baseline to Date of Death from Any Cause (Estimated up to 14 Months)

External Links

•   Click here for more information about this study: A Study of LY3039478 in Participants with Advanced Cancer