Status:
COMPLETED
Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies
Lead Sponsor:
AstraZeneca
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00413686
Start Date
December 1 2006
End Date
May 1 2010
Last Update
December 6 2010
Active Locations (2)
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1
Research Site
Baltimore, Maryland, United States
2
Research Site
Detroit, Michigan, United States