Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multi-center, dose-escalation, Phase I study to evaluate the safety, tolerability, and pharmacokinetics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with gemcitabine. The study is sponsored by AstraZeneca.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective

• ECOG performance status of 0 or 1

• Patient and tumor type must be suitable for treatment with weekly standard gemcitabine.

Exclusion Criteria:

• Inadequate bone marrow reserve, inadequate liver function or impaired renal function

• Any troponin elevation (above normal range)

• Stage II, III, or IV cardiac status, according to New York Heart Association (NYHA) classification; recent history (ie, within 6 months) of coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infarction [MI])

• Any prior anthracycline treatment