A Study of LY3007113 in Participants With Advanced Cancer

Phase 1

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
LY3007113	LY3007113	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests)	Baseline through Study Completion (up to 170 Days)	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

Name	Time	Method
The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)	Baseline through Study Completion (up to 170 Days)	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: 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
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: 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

Locations (1): 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.
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San Antonio, Texas, United States