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OpenTrials
Completed

NCT Number: NCT00636545

Genasense as a 2-hour Intravenous Infusion in 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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oblimersen (Genasense)

Drug

Intravenous

Other names: Oblimersen, Oblimersen sodium, Genasense, G3139, Bcl-2 antisense oligonucleotide

Primary outcomes

  1. 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

Secondary outcomes

  1. Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2)

    Time frame: During treatment phase

Sponsors and collaborators

Lead sponsor

Genta Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Mar 14, 2008
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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