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AZD1152 in Patients With Advanced Solid Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00338182
First received: June 16, 2006
Last updated: July 18, 2016
Last verified: July 2016
  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 part A
Drug: AZD1152 part B
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 2-hour or 48-hour Intravenous Infusions in Patients With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG) [ Time Frame: Throughout the study. Approximately 9 months for most patients. ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed through the incidence of adverse events. Adverse events will include significant findings on vital signs, clinical chemistry/haematology, coagulation parameters and electrocardiograms (ECGs).


Secondary Outcome Measures:
  • Assessment of pharmacodynamic biomarker changes [ Time Frame: Biopsies of tumour at baseline and Cycle 1 [at pre-dose, after Screening to Day 1; and between Days 16-19 (preferrably within 24 hours of completing infusions on Day 17 (Part A) and Day 16 (Part B).] ] [ Designated as safety issue: No ]
    Evaluation of AZD1152 activity in the tumour by assessment of pharmacodynamic biomarker changes which may include, but are not limited to biomarkers of Aurora kinase activity.


Enrollment: 43
Study Start Date: May 2006
Estimated Study Completion Date: June 2017
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD1152
AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment)
Drug: AZD1152 part A
48-hour continuous intravenous infusion
Drug: AZD1152 part B
2-hour intravenous infusion

  Eligibility

Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00338182     History of Changes
Other Study ID Numbers: D1531C00002 
Study First Received: June 16, 2006
Last Updated: July 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Solid tumor

ClinicalTrials.gov processed this record on September 26, 2016