Galunisertib (LY2157299) Plus Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma (HCC)
NCT02906397 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2022-03-25
Summary
To determine the safety and tolerability of galunisertib when combined with Stereotactic Body Radiotherapy (SBRT) (hypofractionated radiation).
Conditions
- ADVANCED HEPATOCELLULAR CARCINOMA (HCC)
Interventions
- DRUG
-
Galunisertib 150mg by mouth twice a day
on days 1-14 of 28 day cycles
- RADIATION
-
Stereotactic Body Radiotherapy (SBRT)
18GY delivered in one fraction between C1D15 and C1D28
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
Kim Reiss Binder, MD · Abramson Cancer Center at Penn Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-30
- Primary Completion
- 2021-07-21
- Completion
- 2021-07-21
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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