Solid Tumors
Conditions
Keywords
Genasense, oblimersen, antisense, Bcl-2 antisense, Solid Tumors
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.
Interventions
DRUGOblimersen (Genasense)
Intravenous
Sponsors
Genta Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2) | During treatment phase |
Countries
United States
Outcome results
None listed