Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Malignant Lymphoma

Advanced Solid Malignancies

Treatments

Drug: AZD1208

Study type

Interventional

Funder types

Industry

Identifiers

NCT01588548

D4510C00005

Details and patient eligibility

About

The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma

Full description

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients with Advanced Solid Malignancies including Malignant Lymphoma

Enrollment

43 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study
Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist
Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks.
Patients who have at least one lesion that can be accurately assessed

Exclusion criteria

Patients who have recently received or are receiving prohibited medications or treatments
Patients who have any unresolved side effects of previous treatments
Patients who have spinal cord compression or brain metastases
Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus [HIV] infection)
Patients with significant abnormal ECG findings