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

Phase 1

Terminated

• Conditions: Advanced Solid Malignancies; Advanced Solid Tumors; Cancer
• Interventions: Drug: AZD7762; Drug: Irinotecan

• Registration Number: NCT00473616
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-15
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-10
• Last Update Posted: 2011-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD7762	AZD7762 monotherapy followed by AZD7762 + irinotecan
1	Irinotecan	AZD7762 monotherapy followed by AZD7762 + irinotecan

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Research site; 🇺🇸 Nashville, Tennessee, United States

Research Site; 🇺🇸 New York, New York, United States