Solid Tumors Clinical Trial
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.
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Research Site | Clichy | |
United Kingdom | Research Site | Sutton | Surrey |
United States | Research Site | Houston | Texas |
United States | Research Site | New York | New York |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, France, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of AZD8055 | Assessed at all visits | Yes | |
Secondary | To identify early signals of anti-tumour activity | Visits 1, 5, and 9 and 11 | No | |
Secondary | To identify early signals of anti-tumor activity | Visits 1, 5, 9 and 13 | No |
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