Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

Phase 1

Terminated

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

• Registration Number: NCT00937664
• Lead Sponsor: AstraZeneca

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.

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: 2009-07
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-02-04
• Last Update Posted: 2011-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD7762 + gemcitabine	AZD7762	AZD7762 administered alone and in combination with gemcitabine
AZD7762 + gemcitabine	gemcitabine	AZD7762 administered alone and in combination with gemcitabine

Primary Outcome Measures

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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Minami-ku, Fukuoka, Japan