Trial Information
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
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Part A: Number of patients with dose limiting toxicities (DLTs) [Maximum Tolerated Dose (MTD) is defined as the maximum dose level below the dose level at which 2 patients of a cohort (3 to 6 patients) experience DLTs during cycle 1.]
Outcome Time Frame:
first 21 day cycle of once daily dosing
Safety Issue:
Yes
Principal Investigator
Joseph P Eder, MD
Investigator Role:
Study Director
Investigator Affiliation:
AZ
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
D4510C00005
NCT ID:
NCT01588548
Start Date:
July 2012
Completion Date:
December 2013
Related Keywords:
- Advanced Solid Malignancies
- Malignant Lymphoma
- Advanced solid malignancies
- Malignant lymphoma
- Neoplasms
- Lymphoma