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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00502567
First received: July 16, 2007
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: January 2005
Study Completion Date: June 2011
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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®
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00502567     History of Changes
Other Study ID Numbers: D8480C00008
Study First Received: July 16, 2007
Last Updated: July 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
advanced solid tumors
AZD2171
Phase I

Additional relevant MeSH terms:
Neoplasms
Fluorouracil
Pemetrexed
Irinotecan
Docetaxel
Cetuximab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on July 20, 2014