NCT00338182

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2006

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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 23, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2008

Completed
8.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

June 16, 2006

Last Update Submit

April 21, 2017

Conditions

Tumors

Keywords

Solid tumor

Outcome Measures

Primary Outcomes (1)

  • The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG)

    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).

    Throughout the study. Approximately 9 months for most patients.

Secondary Outcomes (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).]

Study Arms (1)

AZD1152

EXPERIMENTAL

AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment)

Drug: AZD1152 part ADrug: AZD1152 part B

Interventions

AZD1152 part ADRUG

48-hour continuous intravenous infusion

AZD1152
AZD1152 part BDRUG

2-hour intravenous infusion

AZD1152

Eligibility Criteria

Age18 Years - 130 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 one measurable or non-measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Boston, Massachusetts, United States

Location

Research Site

New York, New York, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Emerging Oncology Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

May 23, 2006

Primary Completion

June 6, 2008

Study Completion

March 1, 2017

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations

US(2)