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Completed

NCT Number: NCT00704366

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

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

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Key information

Conditions

Solid Tumor

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Takatsuk, Osaka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD0530

Drug

oral, tablet, once daily, dose will be variable

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 24, 2008
Registry last updated
May 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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