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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

One year

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

GPK109

NCT ID:

NCT00636545

Start Date:

May 2007

Completion Date:

March 2010

Related Keywords:

  • Solid Tumors
  • Genasense
  • oblimersen
  • antisense
  • Bcl-2 antisense
  • Solid Tumors
  • Neoplasms

Name

Location

South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229