NCT01839604

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2013

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 6, 2017

Completed
Last Updated

March 6, 2017

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

March 21, 2013

Results QC Date

February 1, 2016

Last Update Submit

January 13, 2017

Conditions

Advanced Adult Hepatocellular CarcinomaHepatocellular Carcinoma Metastatic

Keywords

Child-Pugh A to B7,Advanced/Metastatic Hepatocellular Carcinoma,AZD9150,Antisense Oligonucleotide Inhibitor of STAT3

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Dose Limiting Toxicities During Cycle 1

    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.

    DLT assessment window - Cycle 1 (22 days)

Secondary Outcomes (3)

  • 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.

Study Arms (1)

AZD9150

EXPERIMENTAL

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

Drug: AZD9150

Interventions

AZD9150DRUG

Intravenous infusion over 3 hours.

Also known as: ISIS 481464
AZD9150

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Hong Kong, Hong Kong

Location

Research Site

Chūōku, Japan

Location

Research Site

Kashiwa-shi, Japan

Location

Research Site

Matsuyama, Japan

Location

Research Site

Seoul, South Korea

Location

Research Site

Tainan, Taiwan

Location

Research Site

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

danvatirsen

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Limitations and Caveats

The overall study objectives were achieved earlier than anticipated, so recruitment was stopped and the study was considered complete. In turn multiple dose PK profiles were not obtained during the study expansion phase.

Results Point of Contact

Title
Martin Scott, MD/PhD
Organization
AstraZeneca Pharmaceuticals LP
Martin.Scott@astrazeneca.com
Martin.Scott@astrazeneca.com

Study Officials

  • Frank Neumann, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

April 25, 2013

Study Start

May 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 6, 2017

Results First Posted

March 6, 2017

Record last verified: 2016-05

Locations

JP(3)TW(2)HK(1)KR(1)