Back to resultsA Study of LY3007113 in Participants With Advanced Cancer
Primary Purpose
Metastatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3007113
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic for which available standard therapies have failed to provide clinical benefit for their disease
- For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma
- For Dose Confirmation (Part B): cancer, either a solid tumor or a lymphoma
- Have the presence of measureable or non-measureable disease (Part A) or measureable disease (Part B) as defined by the Response Evaluation Criteria in Solid Tumors or the Revised Response Criteria for Malignant Lymphoma
- Have adequate hematologic, hepatic and renal function
- Have a performance status less than or equal to 2 on the Eastern Cooperative Oncology Group scale
- Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents
- Have an estimated life expectancy of greater than or equal to 12 weeks
- Are able to swallow capsules
Exclusion Criteria:
- Have an echocardiogram with clinically significant abnormalities
- For Dose Escalation (Part A): Have central nervous system malignancy or metastasis
- For Dose Confirmation (Part B): Have symptomatic central nervous system malignancy or metastasis
- Have an acute leukemia
- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and stopped all therapy for that disease for a minimum of 3 years
- Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug
Sites / Locations
- 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.
- 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.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LY3007113
Arm Description
Study has a dose escalation phase (Part A) and dose confirmation phase (Part B). Participants in the dose escalation phase will receive 1 of 6 doses of LY3007113 administered orally every 12 hours for at least one cycle. Participants in the dose confirmation phase will receive the maximum tolerated dose from the dose escalation phase administered orally every 12 hours for at least 1 cycle. Three days prior to the start of the first cycle, participants will receive 1 dose at their assigned level to allow for the collection of single dose pharmacokinetics. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Outcomes
Primary Outcome Measures
Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests)
Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Secondary Outcome Measures
The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter without notable worsening of additional tumors that were qualitatively assessed.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113
Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01463631
Brief Title
A Study of LY3007113 in Participants With Advanced Cancer
Official Title
A Phase 1 Study of LY3007113, a p38 MAPK Inhibitor, in Patients With Advanced Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the safety and tolerability of different doses of an experimental treatment in participants with advanced cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3007113
Arm Type
Experimental
Arm Description
Study has a dose escalation phase (Part A) and dose confirmation phase (Part B). Participants in the dose escalation phase will receive 1 of 6 doses of LY3007113 administered orally every 12 hours for at least one cycle. Participants in the dose confirmation phase will receive the maximum tolerated dose from the dose escalation phase administered orally every 12 hours for at least 1 cycle. Three days prior to the start of the first cycle, participants will receive 1 dose at their assigned level to allow for the collection of single dose pharmacokinetics. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Intervention Type
Drug
Intervention Name(s)
LY3007113
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests)
Description
Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Time Frame
Baseline through Study Completion (up to 170 Days)
Secondary Outcome Measure Information:
Title
The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
Description
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter without notable worsening of additional tumors that were qualitatively assessed.
Time Frame
Baseline through Study Completion (up to 170 Days)
Title
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113
Time Frame
Cycle 1 Days -3, -2, -1, 1: Predose to 48 hours Postdose
Title
Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113
Time Frame
Cycle 1 Days 28 and 29, Cycle 2 Day 1: Predose to 24 hours Postdose
Title
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113
Time Frame
Cycle 1 Day -3 (single dose): Predose to 48 hours Postdose; Day 28 (multiple dose): Predose to 24 hours Postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic for which available standard therapies have failed to provide clinical benefit for their disease
For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma
For Dose Confirmation (Part B): cancer, either a solid tumor or a lymphoma
Have the presence of measureable or non-measureable disease (Part A) or measureable disease (Part B) as defined by the Response Evaluation Criteria in Solid Tumors or the Revised Response Criteria for Malignant Lymphoma
Have adequate hematologic, hepatic and renal function
Have a performance status less than or equal to 2 on the Eastern Cooperative Oncology Group scale
Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents
Have an estimated life expectancy of greater than or equal to 12 weeks
Are able to swallow capsules
Exclusion Criteria:
Have an echocardiogram with clinically significant abnormalities
For Dose Escalation (Part A): Have central nervous system malignancy or metastasis
For Dose Confirmation (Part B): Have symptomatic central nervous system malignancy or metastasis
Have an acute leukemia
Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and stopped all therapy for that disease for a minimum of 3 years
Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
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.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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A Study of LY3007113 in Participants With Advanced Cancer
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