A Phase I Study of G3139 Subcutaneous in Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tumors

Keywords

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ECOG MRT NCI CTC SAE Short Intravenous Infusion to Patients with Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Clinical Research Institute for Drug Development

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GPKS106

Identifier Type: -

Identifier Source: org_study_id