Overview

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