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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636545
• Other study ID #: GPK109
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2007
• Last updated: April 4, 2012
• Start date: May 2007
• Est. completion date: March 2010

Study information

• Verified date: January 2009
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2010
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• Oblimersen (Genasense)
Intravenous
• Oblimersen (Genasense)
Intravenous

Locations

Country	Name	City	State
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		One year	Yes
Secondary	Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2)		During treatment phase	No