The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
229
Capsules
50 to 600 milligrams per square meter of body surface area (mg/m2)
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer Agency
Vancouver, British Columbia, Canada
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
University Health Network - Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
...and 6 more locations
Maximum Tolerated Dose(s)
Time frame: Baseline through Cycle 1 (Estimated up to 21 days)
Number of dose limiting toxicities (DLTs)
Time frame: Baseline through Cycle 1 (Estimated up to 21 days)
Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24)
Time frame: Baseline to 24-hours post dose (up to Day 20 in Cycle 1)
Peak plasma concentration (Cmax)
Time frame: Baseline to 24 hours post-dose (up to Day 20 in Cycle 1)
Time to reach maximum plasma concentration (tmax)
Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in white blood cell count
Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in neutrophil count
Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in lymphocyte count
Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Number of participants with tumor response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1)
Time frame: Baseline to study completion (estimated up to 4 years)
Duration of objective response
Time frame: Baseline to study completion (estimated up to 4 years)
Best response
Time frame: Baseline to study completion (estimated up to 4 years)
Progression free survival
Time frame: Baseline to study completion (estimated up to 4 years)
Overall survival
Time frame: Baseline up to 1 year
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