Back to resultsPhase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases
Primary Purpose
Advanced Solid Tumor, Liver Metastases
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
AZD2171
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumor focused on measuring Phase I, AZD2171, advanced solid tumors
Eligibility Criteria
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
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
PK,assess the effects of AZD2171 on surrogate markets of activity and to make a preliminary assessment of anti-tumor activity by measurement of tumor response and time to progression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00501605
Brief Title
Phase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Single centre recruiting approximately 80 patients who are given a rising single, followed by multiple, ascending oral dose of AZD2171, assessing the safety and tolerability of AZD2171 in patients with solid tumors and metastatic liver disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Liver Metastases
Keywords
Phase I, AZD2171, advanced solid tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD2171
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
PK,assess the effects of AZD2171 on surrogate markets of activity and to make a preliminary assessment of anti-tumor activity by measurement of tumor response and time to progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Botwood, BSc, MBBS, MRCP, MFPM
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
J. Drevs, PD
Organizational Affiliation
Klinik fur.Internistische Onkologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Freiburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Phase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases
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