A Study of LY2880070 in Participants With Advanced or Metastatic Cancer (NCT02632448) | Clinical Trial Compass
CompletedPhase 1/2
A Study of LY2880070 in Participants With Advanced or Metastatic Cancer
United States, Canada229 participantsStarted 2016-05-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have an estimated life expectancy of greater than or equal to (≥)12 weeks
* Have adequate organ function
* Have received 1-4 prior systemic therapies for locally advanced or metastatic disease
* Agree to use medically approved contraceptives during the study and for 3 months following the last study treatment
* All females must have a negative serum pregnancy test result, and females of child-bearing potential must have a negative urine pregnancy test result, prior to the first study treatment
* Have tumor lesions considered measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Must be, in the judgment of the investigator, an appropriate candidate for experimental therapy, and no standard therapy would confer clinical benefit
For Part A
* Must have evidence of cancer (solid tumors, excluding glioblastoma and primary brain tumor) that is advanced or metastatic
* For the Metabolism Phenotype Arm in Part A, participants must have a Cytochrome P450 (CYP2D6) poor metabolizer phenotype
For Part B
* Have advanced or metastatic colorectal cancer, triple negative breast cancer (per American Society of Clinical Oncology-College of American Pathology guidelines), epithelial ovarian cancer, endometrial, soft tissue sarcoma, pancreatic cancer
* For TNBC:
* Recurrent/refractory Triple Negative Breast Cancer (TNBC) defined as any beast canc…
What they're measuring
1
Maximum Tolerated Dose(s)
Timeframe: Baseline through Cycle 1 (Estimated up to 21 days)