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AZD1152 in Patients With Advanced Solid Malignancies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by AstraZeneca.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00338182
First received: June 16, 2006
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 48-hour infusion every 14 days and as a 2-hour infusion for 2 consecutive days every 14 days in patients with advanced solid malignancies.


Condition Intervention Phase
Tumors
Drug: AZD1152
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Enrollment: 43
Study Start Date: May 2006
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD1152
    48-hour continuous intravenous infusion
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338182

Locations
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
New York, New York, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Emerging Oncology Medical Science Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00338182     History of Changes
Other Study ID Numbers: D1531C00002
Study First Received: June 16, 2006
Last Updated: October 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Solid tumor

ClinicalTrials.gov processed this record on November 24, 2014