Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055

A Phase I, Open Label, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00973076

Enrollment

Registered

2009-09-09

Start date

2009-08-31

Completion date

2010-12-31

Last updated

2011-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Malignancies, Cancer, Solid Tumors

Keywords

Phase I, cancer, solid tumors, advanced solid malignancies, dose escalation, mTOR Kinase Inhibitor, Japanese

Brief summary

The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.

Interventions

DRUGAZD8055

Tablets, orally administered, twice daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective * Relatively good overall health other than cancer

Exclusion criteria

* Poor bone marrow function (not producing enough blood cells) * Poor liver or kidney function * Serious concomitant illness

Design outcomes

Primary

Measure	Time frame
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.

Secondary

Measure	Time frame
To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours	According to protocol specified schedule, the number of PK samples collected during Cycle 1
To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria)	Every cycle

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026