A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumor
Both
Advanced Solid Tumor
Trial Information
A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors
Inclusion Criteria:
- histologically confirmed metastatic cancer that is not amenable to surgery or
radiation therapy with curative intent
- measurable lesion by CT or other techniques according to RECIST
Exclusion Criteria:
- Inadequate bone marrow reserve
- history of poorly controlled hypertension
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel
Outcome Time Frame:
After 5 weeks of treatment
Safety Issue:
No
Principal Investigator
Jane Robertson
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D8480C00008
NCT ID:
NCT00502567
Start Date:
January 2005
Completion Date:
June 2011
Related Keywords:
- Advanced Solid Tumor
- advanced solid tumors
- AZD2171
- Phase I
- Neoplasms
Name | Location |
|---|---|
| Research Site | Battle Kreek, Michigan |
| Research Site | Chattanooga, Tennessee |
