Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours

Neoplasms Clinical Trial

Official title:

Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) in Patients With Advanced Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475956
• Other study ID #: D8480C00014
• Secondary ID: EuDract #2006-00
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2007
• Last updated: April 14, 2010
• Start date: May 2007
• Est. completion date: October 2009

Study information

• Verified date: April 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written consent

• Cancer diagnosis & stage

• Patients for whom no standard therapy exists

• World Health Organization (WHO) performance status 0-2

• One or more measurable lesions

Exclusion Criteria:

• Prostate cancer

• Untreated unstable brain or meningeal metastases

• Specific laboratory ranges

• Pregnant or breast-feeding women

• Any evidence of severe or uncontrolled diseases

• Participation in other trials within 30 days

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• AZD2171
oral tablet multiple ascending doses 20, 30 or 45 mg
• AZD0530
oral tablet multiple ascending doses 125 mg or 175 mg

Locations

Country	Name	City	State
Germany	Research Site	Essen	Ruhr
Germany	Research Site	Freiburg	Baden-Wurttemberg
Germany	Research Site	Herne	Ruhr

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam		assessed at each visit	No
Secondary	Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530		assessed at each visit	No
Secondary	Safety and efficacy		assessed at each visit	No
Secondary	Genetic variation of pathways targeted by AZD2171 and AZD0530		assessed during study	No