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

AstraZeneca1 site in 1 country58 target enrollmentMay 2013

ConditionsAdvanced Adult Hepatocellular Carcinoma Hepatocellular Carcinoma Metastatic

InterventionsAZD9150

DrugsAZD9150

Overview

Phase: Phase 1
Intervention: AZD9150
Conditions: Advanced Adult Hepatocellular Carcinoma
Sponsor: AstraZeneca
Enrollment: 58
Locations: 1
Primary Endpoint: Number of Participants With Dose Limiting Toxicities During Cycle 1
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 hepatocellular carcinoma.

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 Carcinoma.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

February 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 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

Arms & Interventions

AZD9150

There are two parts, dose escalation phase (Part A) and dose expansion phase (Part B).

Intervention: AZD9150

Outcomes

Primary Outcomes

Number of Participants With Dose Limiting Toxicities During Cycle 1

Time Frame: DLT assessment window - Cycle 1 (22 days)

Cycle 1 was defined as 3 loading doses given on Days 1, 3, and 5 followed by 3 weekly doses given on Days 8, 15, and 22.

Secondary Outcomes

Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Cmax, Using the Plasma Concentration Data.(8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day1 of Cycle1.)
Preliminary Assessment of the Anti-tumour Activity of AZD9150 by Evaluation of Tumour Response.(Every 6 weeks, assessed up to 12 months.)
Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Tmax, Using the Plasma Concentration Data.(8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day 1 of Cycle 1.)