Clinical trial · Interventional
A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) 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
NCT01839604CI-TRIAL-00026303completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Adult Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Hepatocellular Carcinoma Metastatic | Hepatocellular Carcinoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD9150 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZD9150
- description
- There are two parts, dose escalation phase (Part A) and dose expansion phase (Part B).
- interventionNames
- Drug: AZD9150
Primary outcomes (1)
- measure
- Number of Participants With Dose Limiting Toxicities During Cycle 1
- timeFrame
- DLT assessment window - Cycle 1 (22 days)
- description
- 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 (3)
- measure
- Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Cmax, Using the Plasma Concentration Data.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.