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NCT00473616 Clinical Trial

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

Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00473616
Other study ID # D1040C00004
Secondary ID
Status Terminated
Phase Phase 1
First received May 14, 2007
Last updated February 10, 2011
Start date May 2007
Est. completion date January 2011

Study information
Verified date February 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 60
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AZD7762
intravenous infusion
• Irinotecan
intravenous injection

Locations
Country Name City State
United States Research Site Boston Massachusetts
United States Research site Nashville Tennessee
United States Research Site New York New York

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan assessed after each course of treatment No
Secondary To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762. assessed after each course of treatment No
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