Status:
COMPLETED
A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Advanced Adult Hepatocellular Carcinoma
Hepatocellular Carcinoma Metastatic
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
Brief Summary
This is 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 hepatocellu...
Detailed Description
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 Car...
Eligibility Criteria
Inclusion
- Aged at least 18 years. Patient from Japan and Taiwan aged at least 20 years
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01839604
Start Date
May 1 2013
End Date
February 1 2015
Last Update
March 6 2017
Active Locations (7)
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1
Research Site
Hong Kong, Hong Kong
2
Research Site
Chūōku, Japan
3
Research Site
Kashiwa-shi, Japan
4
Research Site
Matsuyama, Japan