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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014