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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

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222157
Enrollment
Unknown
Registered
2013-07-29
Start date
2013-07-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Adult Hepatocellular Carcinoma, Hepatocellular Carcinoma Metastatic

Interventions

investigational material(s) Generic name etc : AZD9150 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -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.

Exclusion criteria

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026