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
18 Years
N/A
Both
Advanced Adult Hepatocellular Carcinoma, Hepatocellular Carcinoma Metastatic
Trial Information
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
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.
Inclusion Criteria:
- Aged at least 18 years. Patient from Japan 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Investigation of the safety and tolerability of AZD9150 when given intravenously to patients with hepatocellular carcinoma and determine a recommended phase II dose and schedule (RP2D) by evaluating dose limiting toxicities occurred during cycle 1.
Outcome Description:
For routine safety monitoring, visit scheduled on Screening, Cycle1Day1, 3, 5, 8, 15 and 22, Day1, 8, 15 and 22 of every Cycle until study discontinuation and 28-day follow up,assessed up to 12 months.
Outcome Time Frame:
Assessed up to12 months
Safety Issue:
Yes
Principal Investigator
Becker Hewes, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
D5660C00001
NCT ID:
NCT01839604
Start Date:
May 2013
Completion Date:
August 2014
Related Keywords:
- Advanced Adult Hepatocellular Carcinoma
- Hepatocellular Carcinoma Metastatic
- Child-Pugh A to B7,
- Advanced/Metastatic Hepatocellular Carcinoma,
- AZD9150,
- Antisense Oligonucleotide Inhibitor of STAT3
- Carcinoma
- Carcinoma, Hepatocellular
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