A Phase I Single Centre 2-part Open Study to Assess the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients With Advanced Solid Malignant Tumors and Liver Metastases
18 Years
N/A
Both
Advanced Solid Tumor, Liver Metastases
Trial Information
A Phase I Single Centre 2-part Open Study to Assess the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients With Advanced Solid Malignant Tumors and Liver Metastases
Inclusion Criteria:
- Provision of written informed consent
- Male/female, 18 yr or over
- WHO status 0-2
- Refractory advanced solid tumor
Exclusion Criteria:
- Radiotherapy within 4 weeks of starting AZD2171 treatment
- Low haemoglobin level
- Low platelet or neutrophil counts
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
primary objective is to evaluate the safety and tolerability of ascending single&multiple oral doses of AZD2171 by assessment of AEs,BP,HR,RR,ECG,clinical chemistry,haematology,urinalysis incl 24hr collection for protein&creatinine and physical exam.
Principal Investigator
Nick Botwood, BSc, MBBS, MRCP, MFPM
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
D8480C00001
NCT ID:
NCT00501605
Start Date:
February 2003
Completion Date:
February 2006
Related Keywords:
- Advanced Solid Tumor
- Liver Metastases
- Phase I
- AZD2171
- advanced solid tumors
- Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Liver Neoplasms
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