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| Name | Class |
|---|---|
| Agennix | INDUSTRY |
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This is a phase I dose escalating study of oral satraplatin in combination with Abraxane administered weekly for three out of every four weeks in patients with advanced solid cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| satraplatin abraxane | Experimental | Satraplatin and abraxane will be given in escalating cohorts on a 3 + 3 design from satraplatin 40mg/m2 and abraxane 80mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Satraplatin | Drug | Dose escalation of 40, 60 and 80 mg/m²/day on days 1-5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine a safe dose of oral Satraplatin to be administered for 5 consecutive days every week in combination with a 30 minute infusion of Abraxane administered weekly for 3 weeks out of 4 weeks. | Upon completion of dose escalation and determination of MTD |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the toxicity profile of Satraplatin combined with Abraxane | Upon completion of study | |
| To determine the anti-tumor effect of the combination of Satraplatin and Abraxane | Upon completion of study |
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Inclusion Criteria:
Hemoglobin ≥ 9 g/dL leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) ≤2.5 x institutional upper limit of normal creatinine within 1.5 x ULN OR creatinine clearance ≥50 mL/min/1.73 m² for patients with creatinine levels above institutional normal.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hari Deshpande, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University, Comprehensive Cancer Center | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| C081294 | satraplatin |
| D010984 | Platinum |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Abraxane | Drug | Dose escalation of 80 and 100 mg/mm²/day on days 1,8,15,22 every 28 days |
|
|
| To determine if the administration of Satraplatin alters the pharmacokinetic profile of weekly Abraxane | Upon completion of study |
| D008670 |
| Metals |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |