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A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a Continuous 48-hour Intravenous Infusion in Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Tumors

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Trial Information

A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a Continuous 48-hour Intravenous Infusion in Patients With Advanced Solid Malignancies


Inclusion Criteria:



- Histological or cytological confirmation of a solid, malignant tumour

- At least one measurable or non-measurable site of disease as defined by Response
Evaluation Criteria in Solid Tumors (RECIST) criteria.

Exclusion Criteria:

- Participation in an investigational drug study within the 21 days prior to therapy or
those who have not recovered from the effects of an investigational study drug

- Recent major surgery within 4 weeks prior to entry into the study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Emerging Oncology Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D1531C00002

NCT ID:

NCT00338182

Start Date:

May 2006

Completion Date:

January 2013

Related Keywords:

  • Tumors
  • Solid tumor

Name

Location

Research SiteBeverly, Massachusetts  
Research SiteAlbany, New York