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A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies


Phase 1
20 Years
75 Years
Not Enrolling
Both
Advanced Solid Tumor

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Trial Information

A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies


Inclusion Criteria:



- advanced solid tumors

- life expectancy is 12 weeks or longer

Exclusion Criteria:

- patient with uncontrolled brain metastases

- patient with inappropriate laboratory test values

- patient with poorly controlled hypertension

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

Assessed at each visit for 4 weeks

Safety Issue:

No

Principal Investigator

Jane Robertson

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

D8480C00023

NCT ID:

NCT00503477

Start Date:

October 2005

Completion Date:

January 2009

Related Keywords:

  • Advanced Solid Tumor
  • Japan
  • Phase I
  • solid tumor
  • AZD2171
  • Neoplasms

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