AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00704366

Purpose

This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.

Condition	Intervention	Phase
Solid Tumor	Drug: AZD0530	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: AZD0530

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety and Tolerability of AZD0530 in Patients With Advanced Solid Malignancies

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of this study is to evaluate the safety and tolerability of AZD0530 in Japanese patients with advanced solid malignancies by assessment of AEs, vital signs, ECG, laboratory findings, thoracic imaging and pulmonary function test. [ Time Frame: Assessed on an ongoing basis after starting daily dosing with AZD0530 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the single and multiple dose PK of AZD0530 when administered orally to patients with advanced solid malignancies by assessment of Cmin, Cmax, tmax, Cssmax, Cssmin, AUC0-t, AUC0-24, AUC, AUCss0-24, CL/F, t1/2 and R [ Time Frame: 1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days. ] [ Designated as safety issue: No ]
Tumor response [ Time Frame: at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD0530	Drug: AZD0530 oral, tablet, once daily, dose will be variable

Eligibility

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed advanced carcinoma / solid tumour of known primary site, which is refractory to standard therapies or for which no standard therapy exists
World Health Organisation (WHO) performance status 0 to 2
Life expectancy of at least 12 weeks

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704366

Contacts

Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com
Contact: AstraZeneca Information (outside US)	800-236-9933

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Mary Stuart, MD	AstraZeneca
Principal Investigator:	Narikazu Boku, MD	Shizuoka Cancer Center

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Dr Mary Stuart, BSc MSc MB BCh BAO MRCPI, Medical Science Director Emerging Oncology Product Team 1 )
Study ID Numbers:	D8180C00021
Study First Received:	June 23, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00704366 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:

Advanced carcinoma

Study placed in the following topic categories:

Carcinoma

ClinicalTrials.gov processed this record on May 06, 2009