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.

AstraZeneca1 site in 1 country64 target enrollmentJuly 2008

ConditionsSolid Tumors

InterventionsAZD8055

DrugsAZD8055

Overview

Phase: Phase 1
Intervention: AZD8055
Conditions: Solid Tumors
Sponsor: AstraZeneca
Enrollment: 64
Locations: 1
Primary Endpoint: Safety and tolerability of AZD8055
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

November 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

1

The 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.

Intervention: AZD8055