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


Phase 1
20 Years
N/A
Not Enrolling
Both
Solid Tumor

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

Assessed on an ongoing basis after starting daily dosing with AZD0530

Safety Issue:

Yes

Principal Investigator

Mary Stuart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

AstraZeneca

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

D8180C00021

NCT ID:

NCT00704366

Start Date:

June 2008

Completion Date:

May 2011

Related Keywords:

  • Solid Tumor
  • Advanced carcinoma

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