A Phase I Study of G3139 Subcutaneous in Solid Tumors
Completed · Phase 1
Conditions studied: Tumors
In brief
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.
Key facts
- Study ID
- NCT00543231
- Run by
- Genta Incorporated
- People needed
- 8
- Starts
- 2005-12-01
- Expected to finish
- 2006-12-01
- Last updated by the study team
- 2007-10-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Research Institute for Drug Development — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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