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

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT00413686

Run by

AstraZeneca

People needed

42

Starts

2006-12-01

Expected to finish

2010-05-01

Last updated by the study team

2010-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Baltimore, Maryland, United States
• Research Site — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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