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AZD1152 in Patients With Advanced Solid Malignancies

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00338182
Collaborator
(none)
43
Enrollment
2
Locations
1
Arm
129.3
Actual Duration (Months)
21.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: AZD1152 part A
  • Drug: AZD1152 part B
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Actual Study Start Date :
May 23, 2006
Actual Primary Completion Date :
Jun 6, 2008
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG) [Throughout the study. Approximately 9 months for most patients.]

    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

  1. Assessment of pharmacodynamic biomarker changes [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).]]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 130 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Research Site Boston Massachusetts United States
2 Research Site New York New York United States

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Study Director: Emerging Oncology Medical Science Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00338182
Other Study ID Numbers:
  • D1531C00002
First Posted:
Jun 20, 2006
Last Update Posted:
Apr 24, 2017
Last Verified:
Apr 1, 2017
Keywords provided by AstraZeneca
Solid tumor
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Apr 24, 2017