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AZD8055

Phase 1

Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jul 11, 2012

Success Probability

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Trial Design

UNCONTROLLEDDMC
Total Trials2
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

AZD8055 · 3 trials · 4 indications

Phase 1 3
NCT00999882Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer PatientsCancer
COMPLETED26 Analytics
NCT00973076Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055Cancer
COMPLETED19 Analytics
NCT00731263A Study of Tor Kinase Inhibitor in Advanced TumorsSolid Tumors
COMPLETED64 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
CancerUnlock trial analytics
PHASE1COMPLETED
Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055
CancerUnlock trial analytics
PHASE1COMPLETED
A Study of Tor Kinase Inhibitor in Advanced Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination)
Every week for Cycle 1 and 2, every 2 weeks from cycle 3 onwards, every 4 weeks from cycle 7 onwards
Evaluate the pharmacokinetics of AZD8055 following both single and multiple dosing
Blood samples on 6 occasions during the first Cycle of the study (28 days)
Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)
Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.
Safety and tolerability of AZD8055
Assessed at all visits

Secondary Endpoints

To make a preliminary assessment of efficacy
Every 4 weeks
To investigate the possible relationship between plasma concentration of AZD8055 concentrations and the extent of liver impairment.
During Cycle 1 of the study - blood samples before study treatment and then on Day 1, 3, 10, 17, 24, 30 and then on day 1 of every cycle
Evaluate the change in Phosphorylation levels of certain biomarkers before and after treatment with AZD8055
Blood samples x 3 times on Day 1 of the first cycle
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD8055EXPERIMENTALDose escalation
1EXPERIMENTALThe study will start with AZD8055 formulated in a liquid solution prior to the tablet formulation becoming available. The tablet formulation will be introduced in Part A at the beginning of a new cohort at an appropriate dose, no higher than the dose of the liquid formulation in the last completed evaluated cohort. Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment.

Interventions

NameTypeDescription
AZD8055DRUGDose escalation phase: Tablet taken orally, a single dose of AZD8055 on Day 1, followed by twice daily continuous dosing from Day 3 onwards, till discontinuation or withdrawal.Expansion phase: twice daily continuous dosing from Day 1 onwards till discontinuation or withdrawal.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Advanced stage Hepatocellular Carcinoma (HCC) confirmed by cytology or histology * Advanced stage Hepatocellular Carcinoma (HCC) or metastatic Hepatocellular Carcinoma (HCC) which is inoperable and incurable with standard available treatments * Relatively good overall health o...

Countries:Hong KongSouth KoreaJapanUnited StatesFranceUnited Kingdom
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Frequently asked questions about AZD8055

What is AZD8055 used for?

AZD8055 is an investigational small molecule being studied for the treatment of cancer, including solid tumors and advanced hepatocellular carcinoma. It is a TOR kinase inhibitor developed by AstraZeneca PLC. As of now, it has been evaluated in early-phase clinical trials, but it is not approved for any indication.

What does AZD8055 target?

AZD8055 targets TOR kinase, a key regulator of cell growth and proliferation. By inhibiting this enzyme, the drug aims to disrupt signaling pathways that drive tumor growth. This mechanism is being explored in the context of advanced solid malignancies and liver cancer, though the drug remains in clinical development.

Who makes AZD8055?

AZD8055 is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The company has sponsored clinical trials to evaluate the safety and efficacy of this investigational drug in patients with various types of cancer.

What phase is AZD8055 in?

AZD8055 is in Phase 1 clinical development. All three trials listed for this drug are Phase 1 studies, and they have been completed. The drug is still investigational and has not received regulatory approval for any use. Its development status reflects early-stage evaluation of safety and tolerability.

What clinical trials is AZD8055 in?

AZD8055 has been studied in three completed Phase 1 trials: NCT00731263 in advanced tumors, NCT00973076 in cancer and solid tumors, and NCT00999882 in advanced hepatocellular carcinoma. These trials enrolled a total of 109 patients across the United States, France, the United Kingdom, Japan, Hong Kong, and South Korea.

Is AZD8055 the same as a TOR kinase inhibitor?

AZD8055 is a TOR kinase inhibitor, meaning it works by blocking the activity of TOR kinase enzymes. It is not known by any other drug name, but it is often described by its mechanism of action. The drug is being investigated for its potential role in treating cancer, though it remains in early clinical testing.