A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients With Advanced/Metastatic Hepatocellular Carcinoma
- Conditions
- Advanced Adult Hepatocellular Carcinoma, Hepatocellular Carcinoma Metastatic
- Registration Number
- JPRN-jRCT2080222157
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Histologically or cytologically confirmed HCC (with the exception of fibrolamellar carcinoma or mixed variants of HCC with fibrolamellar histology OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis)
-Relapsed, refractory, intolerant or unlikely to benefit from sorafenib (for example due to comorbidity)
-Metastatic or locally advanced meeting ANY of the criteria below:
-HCC not suitable to receive local therapy
-Disease recurred or was refractory to last therapy (local or systemic)
-Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 8 weeks
Aged at 18 years. Patient from Japan and Taiwan aged at least 20 years.
-More than 2 prior systemic treatments for HCC
-Prior grade 3 hematologic toxicity related to treatment with a JAK or STAT3 inhibitor
-Presence of hepatic encephalopathy within 4 weeks of 1st dose
-Uncontrolled massive ascites
-High likelihood of bleeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method