A study of Tor Kinase inhibitor in advanced tumors
Study identifier:D1600C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2008-002606-19
CTIS identifier:N/A
Study Complete
Official Title
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.
Medical condition
Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD8055
Sex
All
Actual Enrollment
64
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jul 2008
Primary Completion Date: 01 Nov 2010
Study Completion Date: 01 Nov 2010
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 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. | Drug: AZD8055 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. |
Contacts
Investigators
Principal Investigator
Prof Stan Kaye
Royal Marsden Hospital, Sutton, Surrey, England, SM2 5PT
