The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have. In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Administered orally. Dose of 20 to 600 mg, as determined in Part A.
0.2 mg administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15.
500 mg administered IM on Day 1 and Day 15 in cycle 1 and Day 1 every 28 days for additional cycles.
500 mg/m2 administered IV once on Day 1 every 21 days
75 mg/m2 administered IV once on Day 1 every 21 days
Administered orally
Administered orally
UCLA Medical Center
Los Angeles, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Azienda Ospedaliero - Universitaria S. Luigi Gonzaga
Orbassano, Torino, Italy
Fundacion de Investigacion de Diego
San Juan, Puerto Rico
Recommended Phase 2 dose
Time frame: Baseline to disease progression or participant discontinuation (estimated 9 weeks)
Pharmacokinetics: Maximum concentration (Cmax)
Time frame: Predose up to 12 hours postdose
Pharmacokinetics: Time of maximal concentration
Time frame: Predose up to 12 hours postdose
Number of participants with tumor response
Time frame: Baseline to disease progression or participant discontinuation (estimated 9 weeks)
Potential of LY3023414 to inhibit CYP3A4-mediated metabolism
Time frame: Baseline through Cycle 1
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