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

Genta Incorporated

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Oblimersen (Genasense)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00636545

GPK109

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Part 1

Experimental group

Description:

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.

Treatment:

Drug: Oblimersen (Genasense)

Drug: Oblimersen (Genasense)

Part 2

Experimental group

Description:

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.

Treatment:

Drug: Oblimersen (Genasense)

Drug: Oblimersen (Genasense)

Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Oblimersen (Genasense)

Drug: Oblimersen (Genasense)