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Study terminated prematurely due to financial contraints.
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Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.
GMX1777 will be administered as 3-Hour Infusions in Combination with Temozolomide taken orally for the treatment of Metastatic Melanoma. GMX1777 infusion will be given on either day 1, days 1 and 3, or days 1,3, and 5 every 4 weeks. Temozolomide will be administered on 5 consecutive days every 4 weeks. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 40 mg/m2 GMX1777 with Temozolomide |
|
| 2 | Experimental | 50 mg/m2 GMX1777 with Temozolomide |
|
| 3 | Experimental | 62 mg/m2 GMX1777 with Temozolomide |
|
| 4 | Experimental | 80 mg/m2 GMX1777 with Temozolomide |
|
| 5 | Experimental | 100 mg/m2 GMX1777 with Temozolomide |
|
| 6 | Experimental | 125 mg/m2 GMX1777 with Temozolomide |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obatoclax Mesylate | Drug | Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the recommended Phase II dose of GMX1777 in combination with temozolomide | 2 years | |
| Learn more about the side effects of taking GMX1777 in combination with temozolomide | Within the first 4 weeks | |
| Determine the disease response to treatment with GMX1777 in combination with temozolomide | Within the first 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Learn more about how the body processes GMX1777 | Within the fisrt 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Berger, MD | Gemin X, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C520962 | obatoclax |
| C541789 | 1-(2-(2-(2-(2-methoxyethoxy)ethoxy)ethoxy)ethoxycarbonyloxymethyl)-4-(N'-cyano-N''-(6-(4-chlorophenoxy)hexyl)-N-guanidino)pyridinium |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
| Temozolomide | Drug |
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |