Status:
COMPLETED
Genasense as a 2-hour Intravenous Infusion in Subjects With Solid Tumors
Lead Sponsor:
Genta Incorporated
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective is to determine the safety and maximum tolerated dose (MTD) of Genasense administered as a 2-hour intravenous infusion once weekly (Part 1) and twice weekly (Part 2) to patients ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available
- Adequate organ function as determined ≤ 7 days prior to starting study medication
- Eastern Cooperative Oncology Group performance status 0 to 2
- At least 3 weeks and recovery from effects of major prior surgery or other therapy, including chemotherapy, radiation therapy, immunotherapy, or cytokine, biologic, or vaccine therapy
- Exclusion criteria
- Other significant medical disease
- History or presence of leptomeningeal disease
- Coexisting condition that would require the subject to continue therapy during the treatment phase of the study with a drug known to alter renal function
- Pregnant or lactating
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00636545
Start Date
May 1 2007
End Date
March 1 2010
Last Update
April 6 2012
Active Locations (1)
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1
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229