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Phase I Single Ascending Dose/Multiple Ascending Dose in Patients Treated With AZD7762 and Irinotecan

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ClinicalTrials.gov Identifier: NCT00473616
Recruitment Status : Terminated (Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.)
First Posted : May 15, 2007
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
This is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with irinotecan. The study is sponsored by AstraZeneca.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Cancer Advanced Solid Malignancies Drug: AZD7762 Drug: Irinotecan Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-label, Multi-center, Dose-escalation and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.
Study Start Date : May 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
AZD7762 monotherapy followed by AZD7762 + irinotecan
Drug: AZD7762
intravenous infusion

Drug: Irinotecan
intravenous injection
Other Names:
  • Campto®
  • Camptosar®
  • irinotecan hydrochloride




Primary Outcome Measures :
  1. The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan [ Time Frame: assessed after each course of treatment ]

Secondary Outcome Measures :
  1. To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762. [ Time Frame: assessed after each course of treatment ]


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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:

  • Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
  • Must be suitable for treatment with irinotecan
  • Relatively good overall health other than your cancer

Exclusion Criteria:

  • Poor bone marrow function (not producing enough blood cells)
  • Serious heart conditions
  • Poor liver or kidney function
  • Any prior anthracycline treatment

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): NCT00473616


Locations
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
New York, New York, United States
United States, Tennessee
Research site
Nashville, Tennessee, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Peter Langmuir, MD AstraZeneca

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00473616     History of Changes
Other Study ID Numbers: D1040C00004
First Posted: May 15, 2007    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011

Keywords provided by AstraZeneca:
Phase I
solid tumors
solid malignancies
cancer Eligibility

Additional relevant MeSH terms:
Neoplasms
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action