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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00475956
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : April 15, 2010
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: AZD2171 Drug: AZD0530 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: 1
AZD2171 Monotherapy
Drug: AZD2171
oral tablet multiple ascending doses 20, 30 or 45 mg
Other Names:
  • cediranib

Experimental: 2
AZD2171 + AZD0530
Drug: AZD2171
oral tablet multiple ascending doses 20, 30 or 45 mg
Other Names:
  • cediranib

Drug: AZD0530
oral tablet multiple ascending doses 125 mg or 175 mg

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530 [ Time Frame: assessed at each visit ]
  2. Safety and efficacy [ Time Frame: assessed at each visit ]
  3. Genetic variation of pathways targeted by AZD2171 and AZD0530 [ Time Frame: assessed during study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00475956

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Research Site
Freiburg, Baden-Wurttemberg, Germany
Research Site
Essen, Ruhr, Germany
Research Site
Herne, Ruhr, Germany
Sponsors and Collaborators
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Study Director: Jane Roberston AstraZeneca
Principal Investigator: Tanja Trarbach, MD Universitatsklinikum der GHS Essen

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Responsible Party: Jane Robertson, MSD, AstraZeneca Identifier: NCT00475956     History of Changes
Other Study ID Numbers: D8480C00014
EuDract #2006-003505-55
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: April 15, 2010
Last Verified: April 2010
Keywords provided by AstraZeneca:
Advanced Solid Tumour
Lung Cancer
Breast Cancer
Colon Cancer
Gastric Cancer
Liver Cancer
Ovarian Cancer
Pancreatic Cancer
Peritoneal Cancer
Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action