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Optimization for Regorafenib in HCC

NCT04476329 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-12-30

No results posted yet for this study

Summary

This is a randomized, two arm, phase II study of 1st Cycle dose optimization for regorafenib treatment compared to standard dose of regorafenib treatment in HCC patients for whom the physician is intending to treat with regorafenib and who failed any 1st line systemic treatment.

Conditions

Interventions

DRUG

Regorafenib 40 MG

Regorafenib (BAY 73-4506) is an oral small molecule tyrosine kinase inhibitor (TKI) that potently blocks multiple protein kinases, including kinases involved in tumor angiogenesis (vascular endothelial growth factor receptor \[VEGFR\] 1, 2, 3, Tyrosine kinase with immunoglobulin-like and epidermal growth factor-like domains 2 \[TIE2\]), stem cell growth factor receptor (KIT, rearranged during transfection \[RET\], p38-alpha, a member of the mitogen activated protein kinase \[MAPK\] family, proto-oncogene c-RAF \[c-RAF\], proto-oncogene BRAF \[BRAF\], BRAFV600E), metastasis (VEGFR3, platelet-derived growth factor receptor \[PDGFR\], fibroblast growth factor receptor1 \[FGFR1\]) and tumor immunity (colony stimulating factor 1 receptor \[CSF1R\]).

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • SC Liver Research Consortium, LLC

    lead OTHER

Principal Investigators

  • Catherine T Frenette, MD · Scripps MD Anderson Cancer Center

  • Madappa Kundranda, MD · Banner MD Andersen Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2021-10-13
Completion
2021-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04476329 on ClinicalTrials.gov