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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00475956
First received: May 18, 2007
Last updated: April 14, 2010
Last verified: April 2010
History of Changes

May 18, 2007
April 14, 2010
May 2007
October 2008   (final data collection date for primary outcome measure)
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 [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
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, PFTs, clin chem, haematology, urinalysis, ECG and physical exam.
Complete list of historical versions of study NCT00475956 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530 [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
  • Safety and efficacy [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
  • Genetic variation of pathways targeted by AZD2171 and AZD0530 [ Time Frame: assessed during study ] [ Designated as safety issue: No ]
Pharmacokinetics (PK) of AZD2171 alone & in combination with AZD0530; PK of AZD0530 when given in combination with AZD2171; Safety & Efficacy; Genetic variation of pathways targeted by AZD2717 & AZD0530; PK of AZD0530 alone & in combination with AZD2171.
Not Provided
Not Provided
 
Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours
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

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
  • Drug: AZD2171
    oral tablet multiple ascending doses 20, 30 or 45 mg
    Other Names:
    • cediranib
    • RECENTIN™
  • Drug: AZD0530
    oral tablet multiple ascending doses 125 mg or 175 mg
  • Experimental: 1
    AZD2171 Monotherapy
    Intervention: Drug: AZD2171
  • Experimental: 2
    AZD2171 + AZD0530
    Interventions:
    • Drug: AZD2171
    • Drug: AZD0530
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2009
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00475956
D8480C00014, EuDract #2006-003505-55
Not Provided
Jane Robertson, MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Jane Roberston AstraZeneca
Principal Investigator: Tanja Trarbach, MD Universitatsklinikum der GHS Essen
AstraZeneca
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP