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

Study Overview
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Brief Summary
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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.

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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: Oblimersen (Genasense)
* Drug: Oblimersen (Genasense)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>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)<br>* Intravenous<br>* Other names: Bcl-2 antisense oligonucleotide;|
| Experimental: Part 2<br>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)<br>* Intravenous<br>* Other names: Bcl-2 antisense oligonucleotide;|
| Experimental: Cohort 2<br>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)<br>* Intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2) |  | During treatment phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genasense, oblimersen, antisense, Bcl-2 antisense, Solid Tumors