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OpenTrials
Completed

NCT Number: NCT00543231

A Phase I Study of G3139 Subcutaneous in 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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Institute for Drug Development

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide

Drug

Sponsors and collaborators

Lead sponsor

Genta Incorporated

Industry

Registry information

Official study title

A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors

Important dates

Study start
2005
Study completion
2006
First posted
Oct 12, 2007
Registry last updated
Oct 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.