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| Sponsored by: |
Gemin X |
| Information provided by: | Gemin X |
| ClinicalTrials.gov Identifier: | NCT00427856 |
Purpose
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.
| Condition | Intervention | Phase |
|
Lymphoma, Follicular |
Drug: Obatoclax mesylate (GX15-070MS) |
Phase II |
| MedlinePlus related topics: | Cancer Lymphoma |
| ChemIDplus related topics: | Rituximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Open-Label, Phase II Study of Sequential, Single-Agent Obatoclax Mesylate (GX15-070MS)Followed by a Combination With Rituximab to Patients With Previously-Untreated Follicular Lymphoma (FL) |
| Estimated Enrollment: | 36 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
40 mg obatoclax over 3 hrs q/weekly
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Drug: Obatoclax mesylate (GX15-070MS)
Obatoclax weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
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2: Experimental
60 mg obatoclax over 24 hours, q/weekly
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Drug: Obatoclax mesylate (GX15-070MS)
Obatoclax weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
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This is a multi-center, open-label, Phase II study of obatoclax administered alone as a weekly, 3-hour or 24-hour infusion for 12 weeks followed by a combination with rituximab to patients with previously-untreated Follicular Lymphoma. For purposes of clinical evaluations, treatment cycles will occur in 4-week periods. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Gemin X, Inc. ( Mark Berger, MD / VP Clinical Operations ) |
| Study ID Numbers: | GEM014 |
| First Received: | January 25, 2007 |
| Last Updated: | July 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00427856 |
| Health Authority: | United States: Food and Drug Administration |
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