AZD8330 First Time in Man in Patients With Advanced Malignancies

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00454090

First received: March 27, 2007

Last updated: August 23, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 27, 2007

Last Updated Date

August 23, 2011

Start Date ^ICMJE

March 2007

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00454090 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine the PK of AZD8330.
To investigate possible PD/PK relationships
To investigate effect of AZD8330 on pERK in PBMCs

Original Secondary Outcome Measures ^ICMJE

To determine the PK of AZD8330.
To investigate possible PD/PK relationships
To investigate effect of AZD8330 on pERK in PBMCs
Part B only: to investigate effect of AZD8330 on Ki67 and pERK in pre- and post- dose matched paired tumour biopsy

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

AZD8330 First Time in Man in Patients With Advanced Malignancies

Official Title ^ICMJE

A Phase I, Open-Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of AZD8330 in Patients With Advanced Malignancies

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cancer

Intervention ^ICMJE

Drug: AZD8330

oral tablet

Other Name: ARRY-424704

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2011

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Norway

Administrative Information

NCT Number ^ICMJE

NCT00454090

Other Study ID Numbers ^ICMJE

D1536C00001

Has Data Monitoring Committee

Not Provided

Responsible Party

MSD, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Emerging Oncology Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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