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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, Older Adult)
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
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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
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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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Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00502567    
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:
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Neoplasms
Leucovorin
Docetaxel
Fluorouracil
Oxaliplatin
Irinotecan
Pemetrexed
Cetuximab
Cediranib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
 Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Folic Acid Antagonists