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

AstraZeneca

Status and phase

Withdrawn

Phase 1

Conditions

Lymphomas

Advanced Solid Tumours

Cancer

Treatments

Drug: AZD8055

Study type

Interventional

Funder types

Industry

Identifiers

NCT01194193

D1600C00002

Details and patient eligibility

About

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.

Enrollment

63 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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