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Sponsored by: |
Genta Incorporated |
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Information provided by: | Genta Incorporated |
ClinicalTrials.gov Identifier: | NCT00543231 |
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.
Condition | Intervention | Phase |
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Tumors |
Drug: G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | GPKS106 |
Study First Received: | October 10, 2007 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00543231 |
Health Authority: | United States: Food and Drug Administration |
ECOG MRT NCI CTC SAE Short Intravenous Infusion to Patients with Solid Tumors |