Status:
COMPLETED
Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors
Lead Sponsor:
Progen Pharmaceuticals
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and to establish what happens to the drug once inside the body. An escalating dose of PG-11047 will be investig...
Detailed Description
This is an open-label phase I, dose-escalation safety study in subjects with refractory solid tumors. The primary objectives of the study are to assess the safety, tolerability, and pharmacokinetics o...
Eligibility Criteria
Inclusion
- non-hematological malignancy where standard therapeutic measures do not exist or no longer effective.
- ECOG - 0-2.
- Life expectancy \> 3 months.
Exclusion
- chemotherapy or radiotherapy within 4 weeks prior to entering the study.
- previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell transplantation.
- primary brain tumors or active brain metastases
- history of significant or symptomatic cardiac arrhythmia, prior myocardial infarction or evidence of a current significant ventricular conduction abnormality
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00705653
Start Date
March 1 2005
End Date
August 1 2009
Last Update
March 27 2012
Active Locations (1)
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1
University of Chicago, Cancer Research Centre
Chicago, Illinois, United States, 60637