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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: AZD0530

• Registration Number: NCT00704366
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Primary Completion: 2011-01
• Status Verified: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD0530	AZD0530

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Sunto-gun, Shizuoka, Japan