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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumors; Cancer; Advanced Solid Malignancies

Treatments: Drug: Irinotecan; Drug: AZD7762

Study type: Interventional

Funder types: Industry

Identifiers

NCT00473616

D1040C00004

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 1 patient group

1

Experimental group

Description:

AZD7762 monotherapy followed by AZD7762 + irinotecan

Treatment:

Drug: AZD7762

Drug: Irinotecan