A Phase I Study of G3139 Subcutaneous in Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00543231
Recruitment Status : Completed
First Posted : October 12, 2007
Last Update Posted : October 12, 2007
Information provided by:
Genta Incorporated

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.

Condition or disease Intervention/treatment Phase
Tumors Drug: G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors
Study Start Date : December 2005
Study Completion Date : December 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00543231

United States, Texas
Clinical Research Institute for Drug Development
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Genta Incorporated Identifier: NCT00543231     History of Changes
Other Study ID Numbers: GPKS106
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: October 12, 2007
Last Verified: December 2005

Keywords provided by Genta Incorporated:
Short Intravenous Infusion to Patients with Solid Tumors

Additional relevant MeSH terms:
Antineoplastic Agents