Advanced Cancer, Metastatic Cancer, Biliary Tract Carcinoma, Cholangiocarcinoma, Gall Bladder Carcinoma, Solid Tumor, Non-Hodgkin's Lymphoma
Conditions
Interventions
investigational material(s)
Generic name etc : Part A : merestinib (LY2801653)
INN of investigational material : merestinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administra
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Part A: Histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (solid tumors or non-Hodgkin's lymphoma). -Part B: Biliary tract carcinoma that is unresectable, recurrent, or metastatic. The participant must not have received prior systemic front-line therapy for metastatic or resectable disease. -Part A: Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Cheson Criteria. -Part B: Measurable disease as defined by RECIST v1.1. -Adequate organ function including hematologic, hepatic and renal. -Eastern Cooperative Oncology Group (ECOG) scale of 0 or 1. -Are able to swallow tablets. -Part B: A tumor tissue sample is mandatory for biomarker analysis. -Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug. -Females with childbearing potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test less than or equal to 7 days before the first dose of study drug. -A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, breastfeeding must cease from the day of the first study drug administration until at least 3 months after the last administration.
Exclusion criteria
Exclusion criteria: -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety - | — |
Countries
Japan
Outcome results
None listed