Status:
COMPLETED
A Study of Tor Kinase Inhibitor in Advanced Tumors
Lead Sponsor:
AstraZeneca
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00731263
Start Date
July 1 2008
End Date
November 1 2010
Last Update
July 11 2012
Active Locations (4)
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1
Research Site
New York, New York, United States, 10065
2
Research Site
Houston, Texas, United States
3
Research Site
Clichy, France
4
Research Site
Sutton, Surrey, United Kingdom