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Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic 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.
This is a multi-center, open-label, Phase I/II study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Non-Small Cell Lung Cancer are allowed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obatoclax Mesylate + Docetaxel | Experimental | Obatoclax Mesylate 250mL in combination with Docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obatoclax mesylate 250 ml | Drug |
| ||
| Docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| RECIST criteria with at least one lesion equal to or greater than 2.0cm using conventional technique or equal to greater than 1.0cm with spiral comupted tomography (CT) scan in a single dimension | Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral blood counts; Bone marrow aspirates and biopsies | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Viallet, MD | Gemin X Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic College of Medicine | Scottsdale | Arizona | 85259 | United States | ||
| Tower Oncology |
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|
| Beverly Hills |
| California |
| 90210 |
| United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| MedStar Research Institute | Baltimore | Maryland | 21225 | United States |
| Arlington Cancer Center | Arlington | Texas | 76012 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C520962 | obatoclax |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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