AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00704366

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: AZD0530	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I, Open-label, Dose-escalation Study to Assess the Safety and Tolerability of AZD0530 in Patients With Advanced Solid Malignancies

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 AZD0530	Drug: AZD0530 oral, tablet, once daily, dose will be variable

Arm

Intervention/Treatment

Experimental: 1

AZD0530

Drug: AZD0530

oral, tablet, once daily, dose will be variable

Outcome Measures

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. [Assessed on an ongoing basis after starting daily dosing with AZD0530]

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 [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.]
Tumor response [at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Inadequate bone marrow reserve
Inadequate liver function, renal function or low hemoglobin
Unresolved toxicity from anti-cancer therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Takatsuk	Osaka	Japan
2	Research Site	Sunto-gun	Shizuoka	Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair: Mary Stuart, MD, AstraZeneca
Principal Investigator: Narikazu Boku, MD, Saint Marianna University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00704366

Other Study ID Numbers:

D8180C00021

First Posted:

Jun 24, 2008

Last Update Posted:

May 16, 2011

Last Verified:

May 1, 2011

Keywords provided by , ,

Advanced carcinoma

Additional relevant MeSH terms:

Saracatinib

Study Results

No Results Posted as of May 16, 2011