- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00543231
A Phase I Study of G3139 Subcutaneous in Solid Tumors
October 11, 2007 updated by: Genta Incorporated
A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- Clinical Research Institute for Drug Development
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
October 10, 2007
First Submitted That Met QC Criteria
October 11, 2007
First Posted (Estimate)
October 12, 2007
Study Record Updates
Last Update Posted (Estimate)
October 12, 2007
Last Update Submitted That Met QC Criteria
October 11, 2007
Last Verified
December 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPKS106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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