Genasense as a 2-hour Intravenous Infusion in Subjects With Solid Tumors

April 4, 2012 updated by: Genta Incorporated

A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of Genasense Administered as a 2-hour Intravenous Infusion to Subjects With Solid Tumors

The primary objective is to determine the safety and maximum tolerated dose (MTD) of Genasense administered as a 2-hour intravenous infusion once weekly (Part 1) and twice weekly (Part 2) to patients with solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available
  • Adequate organ function as determined ≤ 7 days prior to starting study medication
  • Eastern Cooperative Oncology Group performance status 0 to 2
  • At least 3 weeks and recovery from effects of major prior surgery or other therapy, including chemotherapy, radiation therapy, immunotherapy, or cytokine, biologic, or vaccine therapy

Exclusion criteria

  • Other significant medical disease
  • History or presence 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
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1
Cohort 1- Genasense will be administered as a 2-hour intravenous infusion once weekly for 3 weeks at a dose of 300 mg to the first subject enrolled and, in the absence of dose-limiting toxicity, in increasing increments of 100 mg to each successive subject enrolled to a maximum dose of 1000 mg.
Drug: Oblimersen (Genasense)
Intravenous
Other Names:
  • G3139
  • Genasense
  • Oblimersen
  • Oblimersen sodium
  • Bcl-2 antisense oligonucleotide
Experimental: Part 2
Genasense will be administered as a 2-hour intravenous infusion twice weekly for 3 weeks at a dose established based on Part 1 of the study.
Drug: Oblimersen (Genasense)
Intravenous
Other Names:
  • G3139
  • Genasense
  • Oblimersen
  • Oblimersen sodium
  • Bcl-2 antisense oligonucleotide
Experimental: Cohort 2
Also in Part 1 of the study, Genasense will be administered as a 2-hour intravenous infusion once weekly for 3 weeks at a starting dose of 1100 mg and increasing in increments of 100 mg to the MTD. Patients will be pretreated with a corticosteroid.
Drug: Oblimersen (Genasense)
Intravenous
Other Names:
  • G3139
  • Genasense
  • Oblimersen
  • Oblimersen sodium
  • Bcl-2 antisense oligonucleotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose (MTD) of Genasense administered as a 2-hour IV infusion once a week (Part 1) and twice a week (Part 2) to patients with solid tumors
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2)
Time Frame: During treatment phase
During treatment phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genta Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 11, 2007

First Submitted That Met QC Criteria

March 13, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

April 6, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPK109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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