A Study of Tor Kinase Inhibitor in Advanced Tumors

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: AZD8055

• Registration Number: NCT00731263
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD8055	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.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD8055	Assessed at all visits

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sutton, Surrey, United Kingdom