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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Solid Tumors Cancer Advanced Solid Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AZD7762 monotherapy followed by AZD7762 + irinotecan

Group Type EXPERIMENTAL

AZD7762

Intervention Type DRUG

intravenous infusion

Irinotecan

Intervention Type DRUG

intravenous injection

Interventions

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AZD7762

intravenous infusion

Intervention Type DRUG

Irinotecan

intravenous injection

Intervention Type DRUG

Other Intervention Names

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Campto® Camptosar® irinotecan hydrochloride

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No