Overview

Preliminary Anti-tumour Activity of mTor Kinase Inhibitor in Advanced Tumours

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To investigate the safety and tolerability of AZD8055 intermittent dosing schedules when given orally to patients with advanced solid malignancies and lymphomas. Two intermittent dosing schedules will be explored with increasing doses until a maximum tolerated dose is determined for each schedule.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Criteria
Inclusion Criteria:

- Histological or cytological confirmation of an advanced solid malignant tumour or
lymphoma which is refactory to standard therapies or for which no standard therapy
exists, patients with measurable or non-measurable disease (according to RECIST
criteria)

- WHO performance status 0-2

- 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.

- Any investigational agents or study drugs from a previous clinical study within 30
days, any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the
first dose of study treatment

- 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