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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014