A Study of LY3007113 in Participants With Advanced Cancer

Study Overview
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Brief Summary
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This study evaluates the safety and tolerability of different doses of an experimental treatment in participants with advanced cancer.

Official Title
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A Phase 1 Study of LY3007113, a p38 MAPK Inhibitor, in Patients With Advanced Cancer

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Drug: LY3007113


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3007113<br>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. | Drug: LY3007113<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline through Study Completion (up to 170 Days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline through Study Completion (up to 170 Days) | 
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113 |  | Cycle 1 Days -3, -2, -1, 1: Predose to 48 hours Postdose | 
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113 |  | Cycle 1 Days 28 and 29, Cycle 2 Day 1: Predose to 24 hours Postdose | 
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113 |  | Cycle 1 Day -3 (single dose): Predose to 48 hours Postdose; Day 28 (multiple dose): Predose to 24 hours Postdose |