A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies

AstraZeneca1 site in 1 country24 target enrollmentJuly 2009

ConditionsCancer Solid Tumors Advanced Solid Malignancies

InterventionsAZD7762 gemcitabine

DrugsAZD7762 gemcitabine

Overview

Phase: Phase 1
Intervention: AZD7762
Conditions: Cancer
Sponsor: AstraZeneca
Enrollment: 24
Locations: 1
Primary Endpoint: Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

February 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective.
•Must be suitable for treatment with gemcitabine
•Relatively good overall health other than cancer

Exclusion Criteria

•Poor bone marrow function (not producing enough blood cells).
•Poor liver or kidney function.
•Serious heart conditions

Arms & Interventions

AZD7762 + gemcitabine

AZD7762 administered alone and in combination with gemcitabine

Intervention: AZD7762

AZD7762 + gemcitabine

AZD7762 administered alone and in combination with gemcitabine

Intervention: gemcitabine

Outcomes

Primary Outcomes

Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram

Time Frame: Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2

Secondary Outcomes

Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine(According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1)
Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST)(Every 2-3 cycles)