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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
Not Enrolling
Both
Advanced Solid Tumor

Thank you

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 SiteBattle Kreek, Michigan  
Research SiteChattanooga, Tennessee