A Phase I Study of G3139 Subcutaneous in Solid Tumors

Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543231
• Other study ID #: GPKS106
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2007
• Last updated: October 11, 2007
• Start date: December 2005
• Est. completion date: December 2006

Study information

• Verified date: December 2005
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide

Locations

Country	Name	City	State
United States	Clinical Research Institute for Drug Development	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States,