Phase 1
Completed N=39
A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma
Source: ClinicalTrials.gov NCT01839604 ↗Enrolled (actual)
39
Serious AEs
20.5%
Results posted
Mar 2017
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities During Cycle 1 — 0; 1; 1; 2 participants with DLT
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities During Cycle 1 |
0; 1; 1; 2; 3 | — |
| SECONDARY Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Cmax, Using the Plasma Concentration Data. |
5833; 5575; 8984; 11560; 16110 | — |
| SECONDARY Preliminary Assessment of the Anti-tumour Activity of AZD9150 by Evaluation of Tumour Response. |
0; 0; 1; 0; 0 | — |
| SECONDARY Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Tmax, Using the Plasma Concentration Data. |
3.0; 3.4; 2.8; 3.0; 3.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01839604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.