Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Cancer; Solid Tumors; Advanced Solid Malignancies

Treatments: Drug: gemcitabine; Drug: AZD7762

Study type: Interventional

Funder types: Industry

Identifiers

NCT00937664

D1040C00008

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

AZD7762 + gemcitabine

Other group

Description:

AZD7762 administered alone and in combination with gemcitabine

Treatment:

Drug: AZD7762

Drug: gemcitabine