I3O-JE-JSBG
- Conditions
- Advanced Cancer, Metastatic Cancer, Biliary Tract Carcinoma, Cholangiocarcinoma, Gall Bladder Carcinoma, Solid Tumor, Non-Hodgkin's Lymphoma
- Registration Number
- JPRN-jRCT2080223458
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 18
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.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>-
- Secondary Outcome Measures
Name Time Method safety<br>-