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A Study of LY3039478 in Participants With Advanced Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01695005
First received: September 24, 2012
Last updated: April 4, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Neoplasms
Neoplasm Metastasis
Lymphoma
Drug: LY3039478
Drug: Prednisone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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) ]
  • Part B, C, D, E and F: Number of Participants with Tumor Response [ Time Frame: Baseline to disease progression or participant discontinuation (estimated 8 -12 weeks) ]

Secondary Outcome Measures:
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY3039478 [ Time Frame: Predose up to 30 hours post dose ]
  • Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3039478 [ Time Frame: Predose up to 30 hours post dose ]
  • Part A: Number of Participants with Tumor Response [ Time Frame: Baseline to disease progression or participant discontinuation (estimated 8 -12 weeks) ]
  • 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) ]
  • 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) ]
  • 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) ]

Estimated Enrollment: 282
Study Start Date: October 2012
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY3039478 - Dose Escalation
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
Drug: LY3039478
Administered orally
Experimental: LY3039478 - Cohort Expansion
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.
Drug: LY3039478
Administered orally
Experimental: Dose 1 LY3039478 + Prednisone
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.
Drug: LY3039478
Administered orally
Drug: Prednisone
Administered orally
Experimental: Dose 2 LY3039478 + Prednisone
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.
Drug: LY3039478
Administered orally
Drug: Prednisone
Administered orally

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695005

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) 1-317-615-4559

Locations
United States, Florida
University of Miami School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact    305-243-1287      
Principal Investigator: Dr. J.R. Merchan         
United States, Massachusetts
Harvard Medical School Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact    617-632-3000      
Principal Investigator: Jennifer Brown         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact    734-936-7469      
Principal Investigator: David Smith         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact    718-405-8510      
Principal Investigator: Sanjay Goel         
Weill Cornell Medical College Not yet recruiting
New York, New York, United States, 10021-5663
Contact    646-962-2064      
Principal Investigator: John Allan         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact    646-317-5205      
Principal Investigator: Nicole Lamanna         
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. Recruiting
Kobenhavn, Denmark, 2100
Contact: Eli Lilly and Company         
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. Recruiting
Paris, France, 75248
Contact: Eli Lilly and Company         
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. Recruiting
Villejuif, France, 94805
Contact: Eli Lilly and Company         
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. Recruiting
Tübingen, Germany, 72076
Contact: Eli Lilly and Company         
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. Recruiting
Barcelona, Spain, 08035
Contact: Eli Lilly and Company         
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. Recruiting
London, United Kingdom, SE1 9RT
Contact: Eli Lilly and Company         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01695005     History of Changes
Other Study ID Numbers: 14547
I6F-MC-JJCA ( Other Identifier: Eli Lilly and Company )
Study First Received: September 24, 2012
Last Updated: April 4, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 25, 2017