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

NCT ID: NCT00636545

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oblimersen (Genasense)

Intervention Type: DRUG

Intravenous

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.

Group Type: EXPERIMENTAL

Oblimersen (Genasense)

Intervention Type: DRUG

Intravenous

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.

Group Type: EXPERIMENTAL

Oblimersen (Genasense)

Intervention Type: DRUG

Intravenous

Interventions

Oblimersen (Genasense)

Intravenous

Intervention Type: DRUG

Oblimersen (Genasense)

Intravenous

Intervention Type: DRUG

Other Intervention Names

Oblimersen; Oblimersen sodium; Genasense; G3139; Bcl-2 antisense oligonucleotide

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genta Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Countries

United States

Other Identifiers

GPK109

Identifier Type: -

Identifier Source: org_study_id