AZD1152 in Patients With Advanced Solid Malignancies-Study 1
This study has been terminated.
(Efficacy seen in the solid tumour patient population was not sufficient to continue research with AZD1152 monotherapy in solid tumors at that time.)
Information provided by:
First received: July 5, 2007
Last updated: June 19, 2009
Last verified: June 2009
The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Safety and Tolerability [ Time Frame: Assessed at each visit ]
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: Assessed at predetermined timepoints after dose administration ]
- Effect on biomarkers [ Time Frame: Assessed after treatment ]
- Anti-tumor activity [ Time Frame: Assessed after treatment ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||June 2008 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histological or cytological confirmation of a solid, malignant tumour
- At least measurable or non measurable site of disease as defined by modified RECIST 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497731
|Amsterdam, Netherlands |
|Utrecht, Netherlands |
||Jan Schellens, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 5, 2007
||June 19, 2009
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Keywords provided by AstraZeneca:
ClinicalTrials.gov processed this record on August 01, 2014