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

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ClinicalTrials.gov Identifier: NCT00704366
Recruitment Status : Completed
First Posted : June 24, 2008
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:
AstraZeneca

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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 : June 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : May 2011

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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704366


Locations
Japan
Research Site
Takatsuk, Osaka, Japan
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Mary Stuart, BSc MSc MB BCh BAO MRCPI, Medical Science Director Emerging Oncology Product Team 1, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00704366     History of Changes
Other Study ID Numbers: D8180C00021
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011

Keywords provided by AstraZeneca:
Advanced carcinoma

Additional relevant MeSH terms:
Saracatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action