Tumors
Conditions
Keywords
ECOG, MRT, NCI CTC, SAE, Short Intravenous Infusion to Patients with Solid Tumors
Brief summary
Genasense® is currently administered to subjects in clinical studies as a multiple-day continuous intravenous infusion. Subjects are treated on an outpatient basis and carry a pump that delivers the drug through a peripheral or central intravenous line. The route of administration limits the convenience of treatment, and catheter-related complications have been reported. This study is designed to evaluate the pharmacokinetics and safety of G3139 administered by subcutaneuous injection.
Interventions
DRUGG3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide
Sponsors
Genta Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available. Patients with a history of brain metastasis will be eligible if there is no evidence of cerebral edema or treatment with steroids. * Adequate organ function as determined \< 7 days prior to starting study medication * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * At least 3 weeks and recovery from effects of major prior surgery or other therapy including radiation therapy, immunotherapy, cytokine, biological, vaccine and chemotherapy
Exclusion criteria
* Significant medical diesese * History 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. * Use of any investigational drug within 3 weeks prior to starting study medication * Known hypersensitivity to phosphorothioate-containing oligonucleotides * Pregnancy/Lactation
Countries
United States
Outcome results
None listed