A Phase I Study of G3139 Subcutaneous in Solid Tumors

Genta Incorporated

Status and phase

Completed

Phase 1

Conditions

Tumors

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00543231

GPKS106

Details and patient eligibility

About

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.

Enrollment

8 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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