A Study of Tor Kinase Inhibitor in Advanced Tumors

A Phase I/II, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients With Advanced Solid Tumours.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00731263

Enrollment

Registered

2008-08-08

Start date

2008-07-31

Completion date

2010-11-30

Last updated

2012-07-11

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

Conditions

Solid Tumors

Keywords

Cancer, Advance solid tumours, Dose Escalation, Preliminary efficacy, AZD8055, Tor kinase inhibitor, Oral administration

Brief summary

The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.

Interventions

DRUGAZD8055

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histological or cytological confirmation of an advanced solid malignant tumour (or lymphoma Part A only) * Cancer which is refractory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria) can be recruited to Part A * Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients

Exclusion criteria

* Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug. * Patients with abnormal fasting glucose, have type I or II Diabetes or have uncontrolled blood fats and cholesterol * Patients with a history of neurological disease, peripheral or central neuropathy, brain metastases or family history of myopathy are excluded * Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of AZD8055	Assessed at all visits

Secondary

Measure	Time frame
To identify early signals of anti-tumour activity	Visits 1, 5, and 9 and 11
To identify early signals of anti-tumor activity	Visits 1, 5, 9 and 13

Countries

France, United Kingdom, United States

Outcome results

None listed

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