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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

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.

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.

NCT ID

Therapeutic Area

Research Site

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

For routine safety monitoring, visit scheduled on Screening, Cycle1Day1, 3, 5, 8, 15 and 22, Day1, 8, 15 and 22 of every Cycle until study discontinuation and 28-day follow up,assessed up to 12 months.

Age Continuous

Gender, Male/Female

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.

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. 

Safety: All patients who received at least 1 dose of AZD9150

Number of Participants with Dose Limiting Toxicities During Cycle 1

8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1.  From the multiple samples a timecourse is obtained of treatment conc in the plasma over time.  From this curve the associated PK parameters e.g. Cmax are obtained.  For n patients we obtain up to n parameters which can then be averaged.

PK: All dosed patients with reportable AZD9150 plasma concentrations and no important adverse events or protocol deviations that may impact PK

Evaluation of pharmacokinetics (PK) of AZD9150 (following single administrations in patients with HCC) by determining Cmax, using the plasma concentration data.

Tumour response assessment by modified Response Evaluation Criteria in Solid Tumours (RECIST).  Overall tumour response: assessed by mRECIST for HCC overall visit response of CR (disappearance of baseline TLs and NTLs), PR (>=30% decrease in sum of TLs), SD (neither PR nor PD), PD (sum TLs increased >20%), or NE . 

Evaluable for response: Dosed patients with measurable disease at baseline 

Preliminary assessment of the anti-tumour activity of AZD9150 by evaluation of tumour response.

8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1.

Evaluation of pharmacokinetics (PK) of AZD9150 (following single  administrations in patients with HCC) by determining Tmax, using the plasma concentration data.

Overall Study

Note that 39 patients is the number of patients who were actually assigned to treatment out of the total enrolled.  The ecpansion phase consisted of the 3mg/kg group only.

Martin Scott, MD/PhD

8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1, once (pre-dose) on Day 3, 5, 8, 15 and 22 of Cycle1 and Day1 of Cycle2-5. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1, once (pre-dose) on Day 3, 5, 8 and 15 of Cycle1 and 9 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24, 72 hours post-dose) on Day22 Cycle1.

Tumour response assessment by modified Response Evaluation Criteria in Solid Tumours (RECIST).

8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1, once (pre-dose) on Day 3, 5, 8, 15 and 22 of Cycle1 and Day1 of Cycle2-5 For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1, once (pre-dose) on Day 3, 5, 8 and 15 of Cycle1 and 9 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24, 72 hours post-dose) on Day22 Cycle1.

A Phase I/Ib study of AZD9150 (ISIS-STAT3Rx) in patients with advanced/metastatic hepatocellular carcinoma

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