NCT00497731

Brief Summary

The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 2-hour 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
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2005

Longer than P75 for phase_1

Geographic Reach
1 country

2 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

May 1, 2005

Completed
2.2 years 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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

Enrollment Period

3.1 years

First QC Date

July 5, 2007

Last Update Submit

June 19, 2009

Conditions

Solid Tumors

Keywords

Advanced solid tumors

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 after treatment

Interventions

AZD1152DRUG

2-hour 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
  • At least measurable or non measurable site of disease as defined by modified RECIST criteria.

You may not qualify if:

  • Participation in an investigational drug study within 30 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 (2)

Research Site

Amsterdam, Netherlands

Location

Research Site

Utrecht, Netherlands

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

  • Jan Schellens, MD

    NKI

    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

May 1, 2005

Primary Completion

June 1, 2008

Study Completion

April 1, 2009

Last Updated

June 22, 2009

Record last verified: 2009-06

Locations

NL(2)