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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704366
• Other study ID #: D8180C00021
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2008
• Last updated: May 13, 2011
• Start date: June 2008
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• AZD0530
oral, tablet, once daily, dose will be variable

Locations

Country	Name	City	State
Japan	Research Site	Sunto-gun	Shizuoka
Japan	Research Site	Takatsuk	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	No
Secondary	Tumor response		at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks.	No