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

NCT00636545 | Completed Phase 1

• 1 other identifier: GPK109
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

Genasense; oblimersen; antisense; Bcl-2 antisense; Solid Tumors

Outcome Measures

Primary Outcomes (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

  One year

Secondary Outcomes (1)

• Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2)

  During treatment phase

Study Arms (3)

Part 1

EXPERIMENTAL

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)

Part 2

EXPERIMENTAL

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)

Cohort 2

EXPERIMENTAL

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)

Interventions

Oblimersen (Genasense) DRUG

Intravenous

Also known as: Oblimersen, Oblimersen sodium, Genasense, G3139, Bcl-2 antisense oligonucleotide

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (1)

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

oblimersen

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2007
• First Posted: March 14, 2008
• Study Start: May 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2010
• Last Updated: April 6, 2012

Record last verified: 2009-01

Locations

US (1)