NCT00454090

Brief Summary

The primary purpose of this protocol is to investigate the safety and tolerability of AZD8330 (ARRY-424704) in patients with Advanced Malignancies

Trial Health

90
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P75+ for phase_1 cancer

Timeline
Completed

Started Mar 2007

Typical duration for phase_1 cancer

Geographic Reach
2 countries

3 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

March 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

August 24, 2011

Status Verified

August 1, 2011

Enrollment Period

3.6 years

First QC Date

March 27, 2007

Last Update Submit

August 23, 2011

Conditions

Cancer

Keywords

Advanced Malignancies

Outcome Measures

Primary Outcomes (2)

  • To assess safety and tolerability of AZD8330 in patient with advanced malignancies.

  • Outcome variables: Adverse Events, Clinical Chemistry, Haematology, Urinalysis, Vital signs, MUGA scans/echocardiography, ECGs, Ophthalmologic examination, O2 saturation

Secondary Outcomes (3)

  • To determine the PK of AZD8330.

  • To investigate possible PD/PK relationships

  • To investigate effect of AZD8330 on pERK in PBMCs

Interventions

AZD8330DRUG

oral tablet

Also known as: ARRY-424704

Eligibility Criteria

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

You may qualify if:

  • Cancer which is refractory to standard therapies, or no therapies exist;

You may not qualify if:

  • Participated in radiotherapy, biological or chemotherapy within 21 days prior to study start;
  • Hasn't participated in investigation drug study within 30 days;
  • Brain metastases/spinal cord compression unless treated and stable,
  • Off steroids/anticonvulsants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Oslo, Norway

Location

Related Publications (1)

  • Cohen RB, Aamdal S, Nyakas M, Cavallin M, Green D, Learoyd M, Smith I, Kurzrock R. A phase I dose-finding, safety and tolerability study of AZD8330 in patients with advanced malignancies. Eur J Cancer. 2013 May;49(7):1521-9. doi: 10.1016/j.ejca.2013.01.013. Epub 2013 Feb 21.

    PMID: 23433846DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

AZD8330

Study Officials

  • Emerging Oncology Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 27, 2007

First Posted

March 29, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2010

Study Completion

March 1, 2011

Last Updated

August 24, 2011

Record last verified: 2011-08

Locations

US(2)NO(1)