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A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00502567
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : July 27, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: AZD2171 Drug: FOLFOX Drug: Pemetrexed Drug: Irinotecan (administered with & without Cetuximab) Drug: Docetaxel Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors
Study Start Date : January 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : June 2011
Arms and Interventions
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Intervention Details:
    Drug: AZD2171
    oral tablet once daily
    Other Names:
    • cediranib
    • RECENTIN™.
    Drug: FOLFOX
    intravenous infusion
    Other Name: 5-Fluorouracil, Leucovorin and Oxaliplatin
    Drug: Pemetrexed
    intravenous infusion
    Other Names:
    • Alimta®
    • Pemetrexed disodium
    Drug: Irinotecan (administered with & without Cetuximab)
    intravenous injection
    Other Names:
    • Campto®
    • Camptosar®
    • irinotecan hydrochloride
    Drug: Docetaxel
    intravenous infusion
    Other Name: Taxotere®

Outcome Measures
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Primary Outcome Measures :
  1. Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel [ Time Frame: After 5 weeks of treatment ]

Secondary Outcome Measures :
  1. Examine the PK interaction of AZD2171 with one of the 4 different chemotherapeutic regimens. Make a preliminary evaluation of clinical response as measured by objective response rate. [ Time Frame: Assessed at each visit ]

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

Inclusion Criteria:

  • histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent
  • measurable lesion by CT or other techniques according to RECIST

Exclusion Criteria:

  • Inadequate bone marrow reserve
  • history of poorly controlled hypertension
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00502567


Locations
United States, Michigan
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson AstraZeneca
Study Chair: Bijoyesh Mookerjee, MD AstraZeneca
Principal Investigator: Patricia LoRusso, DO Wayne State University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00502567     History of Changes
Other Study ID Numbers: D8480C00008
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: July 27, 2011
Last Verified: July 2011

Keywords provided by AstraZeneca:
advanced solid tumors
AZD2171
Phase I

Additional relevant MeSH terms:
Irinotecan
Cediranib
Cetuximab
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
 Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors