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

Phase 1TerminatedNCT00473616

AstraZeneca60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors Cancer Advanced Solid Malignancies

Interventions

AZD7762DRUG

intravenous infusion

IrinotecanDRUG

intravenous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Research Site

Boston, Massachusetts, United States

Research Site

New York, New York, United States

Research site

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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