NCT00497679

Brief Summary

The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 7-day infusion every week and every 2 weeks in patients with advanced solid malignancies.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
Last Updated

May 14, 2009

Status Verified

May 1, 2009

First QC Date

July 5, 2007

Last Update Submit

May 13, 2009

Conditions

Solid Tumours

Keywords

advanced solid tumours

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    Assessed at each visit

Secondary Outcomes (3)

  • Pharmacokinetics

    Assessed at predetermined timepoints after dose administration

  • Effect on biomarkers

    Assessed after treatment

  • Anti-tumor activity

    Assessed at the end of treatment

Interventions

AZD1152DRUG

7-day continuous intravenous infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological or cytological confirmation of a solid, malignant tumour

You may not qualify if:

  • Participation in an investigational drug study within 21 days prior to entry or who have not recovered from the effects of an investigational study drug
  • Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
  • Recent major surgery within 4 weeks prior to entry to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Manchester, United Kingdom

Location

Research Site

Newcastle, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

MeSH Terms

Interventions

2-((3-((4-((5-(2-((3-fluorophenyl)amino)-2-oxoethyl)-1H-pyrazol-3-yl)amino)quinazolin-7-yl)oxy)propyl)(ethyl)amino)ethyl dihydrogen phosphate

Study Officials

  • David Kerr, MD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 9, 2007

Study Start

August 1, 2006

Study Completion

July 1, 2007

Last Updated

May 14, 2009

Record last verified: 2009-05

Locations

GB(3)