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

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ClinicalTrials.gov Identifier: NCT00636545
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumors Drug: Oblimersen (Genasense) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2010

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:
  • 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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2) [ Time Frame: During treatment phase ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636545


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

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00636545     History of Changes
Other Study ID Numbers: GPK109
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: January 2009

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

Additional relevant MeSH terms:
Oblimersen
Antineoplastic Agents