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A Phase I Study of G3139 Subcutaneous in Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT00543231
First received: October 10, 2007
Last updated: October 11, 2007
Last verified: December 2005

October 10, 2007
October 11, 2007
December 2005
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Complete list of historical versions of study NCT00543231 on ClinicalTrials.gov Archive Site
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A Phase I Study of G3139 Subcutaneous in Solid Tumors
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.

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Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Tumors
Drug: G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
December 2006
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00543231
GPKS106
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Genta Incorporated
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Genta Incorporated
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP