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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00704366
First received: June 23, 2008
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Solid Tumor
Drug: AZD0530
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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. [ Time Frame: Assessed on an ongoing basis after starting daily dosing with AZD0530 ] [ Designated as safety issue: Yes ]

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 [ 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 2008
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD0530
Drug: AZD0530
oral, tablet, once daily, dose will be variable

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by AstraZeneca

Additional 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
Study First Received: June 23, 2008
Last Updated: May 13, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Advanced carcinoma

ClinicalTrials.gov processed this record on July 22, 2014