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.

Study Overview

• Status: Completed
• Conditions: Tumors
• Intervention / Treatment: Drug: G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Research Institute for Drug Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Collaborators and Investigators

• Sponsor: Genta Incorporated

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Study Completion: December 1, 2006

Study Registration Dates

• First Submitted: October 10, 2007
• First Submitted That Met QC Criteria: October 11, 2007
• First Posted (Estimate): October 12, 2007

Study Record Updates

• Last Update Posted (Estimate): October 12, 2007
• Last Update Submitted That Met QC Criteria: October 11, 2007
• Last Verified: December 1, 2005

More Information

Terms related to this study

• Keywords: MRT; ECOG; NCI CTC; SAE; Short Intravenous Infusion to Patients with Solid Tumors
• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Oblimersen
• Other Study ID Numbers: GPKS106