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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
History of Changes
  Purpose

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
Tumors
 Drug: G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Genta Incorporated:

Estimated Enrollment: 8
Study Start Date: December 2005
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543231

Locations
United States, Texas
Clinical Research Institute for Drug Development
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Genta Incorporated
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00543231     History of Changes
Other Study ID Numbers: GPKS106
Study First Received: October 10, 2007
Last Updated: October 11, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Genta Incorporated:
ECOG
MRT
NCI CTC
SAE
Short Intravenous Infusion to Patients with Solid Tumors

ClinicalTrials.gov processed this record on May 16, 2013