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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT00636545
First received: October 11, 2007
Last updated: April 4, 2012
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Solid Tumors
 Drug: Oblimersen (Genasense)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of Genasense Administered as a 2-hour Intravenous Infusion to Subjects With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2) [ Time Frame: During treatment phase ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2007
Study Completion Date: March 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Oblimersen
  • Oblimersen sodium
  • Genasense
  • G3139
  • 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:
  • Oblimersen
  • Oblimersen sodium
  • Genasense
  • G3139
  • 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636545

Locations
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Genta Incorporated
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00636545     History of Changes
Other Study ID Numbers: GPK109
Study First Received: October 11, 2007
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genta Incorporated:
Genasense
oblimersen
antisense
Bcl-2 antisense
Solid Tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013