Genasense as a 2-hour Intravenous Infusion in Subjects With Solid Tumors
- Registration Number
- NCT00636545
- Lead Sponsor
- Genta Incorporated
- 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 with solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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 Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 2 Oblimersen (Genasense) Genasense will be administered as a 2-hour intravenous infusion twice weekly for 3 weeks at a dose established based on Part 1 of the study. Part 1 Oblimersen (Genasense) Cohort 1- Genasense will be administered as a 2-hour intravenous infusion once weekly for 3 weeks at a dose of 300 mg to the first subject enrolled and, in the absence of dose-limiting toxicity, in increasing increments of 100 mg to each successive subject enrolled to a maximum dose of 1000 mg. Cohort 2 Oblimersen (Genasense) Also in Part 1 of the study, Genasense will be administered as a 2-hour intravenous infusion once weekly for 3 weeks at a starting dose of 1100 mg and increasing in increments of 100 mg to the MTD. Patients will be pretreated with a corticosteroid.
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) of Genasense administered as a 2-hour IV infusion once a week (Part 1) and twice a week (Part 2) to patients with solid tumors One year
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2) During treatment phase
Trial Locations
- Locations (1)
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States