Trial Information
A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2 Hour Intravenous Infusion on Two Dose Schedules in Patients With Advanced Solid Malignancies
Inclusion Criteria:
- Histological or cytological confirmation of a solid, malignant tumour
- At least measurable or non measurable site of disease as defined by modified RECIST
criteria.
Exclusion Criteria:
- Participation in an investigational drug study within 30 days prior to entry or who
have not recovered from the effects of an investigational study drug
- Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
- Recent major surgery within 4 weeks prior to entry to the study
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and Tolerability
Outcome Time Frame:
Assessed at each visit
Principal Investigator
Jan Schellens, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NKI
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
D1531C00001
NCT ID:
NCT00497731
Start Date:
May 2005
Completion Date:
April 2009
Related Keywords:
- Solid Tumors
- Advanced solid tumors