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AZD9150

Phase 1

Advanced Adult Hepatocellular Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Mar 6, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01839604A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular CarcinomaPHASE1 COMPLETED 58 — — May 1, 2013Feb 1, 2015Mar 6, 20177 Hong Kong, Japan +2
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Study Endpoints
Primary Endpoints
Number of Participants With Dose Limiting Toxicities During Cycle 1
DLT assessment window - Cycle 1 (22 days)

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 Endpoints
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.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD9150EXPERIMENTALThere are two parts, dose escalation phase (Part A) and dose expansion phase (Part B).
Interventions
NameTypeDescription
AZD9150DRUGIntravenous infusion over 3 hours.
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites7

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 diffi...

Countries:Hong KongJapanSouth KoreaTaiwan
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