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.

AstraZeneca2 sites in 1 country60 target enrollmentMay 2007

ConditionsAdvanced Solid Tumors Cancer Advanced Solid Malignancies

InterventionsAZD7762 Irinotecan

DrugsAZD7762 Irinotecan

Overview

Phase: Phase 1
Intervention: AZD7762
Conditions: Advanced Solid Tumors
Sponsor: AstraZeneca
Enrollment: 60
Locations: 2
Primary Endpoint: The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

January 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility 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

Arms & Interventions

1

AZD7762 monotherapy followed by AZD7762 + irinotecan

Intervention: AZD7762

1

AZD7762 monotherapy followed by AZD7762 + irinotecan

Intervention: Irinotecan

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.(assessed after each course of treatment)