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Sponsors and Collaborators: |
Yale University GPC Biotech |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00473720 |
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.
Condition | Intervention | Phase |
---|---|---|
Advanced Cancers |
Drug: Satraplatin Drug: Abraxane |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Dose Finding Study of the Orally Bioavailable Platinum Analog Satraplatin in Combination With Abraxane (Paclitaxel Protein-Bound Particles) in Advanced Cancers |
Estimated Enrollment: | 30 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Contact: Elin Rowen, R.N., M.S.N. | 203-737-2445 | elin.rowen@yale.edu |
Contact: Sally Ruta | 203-737-1881 | sally.ruta@yale.edu |
United States, Connecticut | |
Yale University, Comprehensive Cancer Center | Recruiting |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | Hari Deshpande, M.D. | Yale University |
Responsible Party: | Yale University School of Medicine ( Hari Deshpande, M.D., Principal Investigator ) |
Study ID Numbers: | 0606001535 |
Study First Received: | May 11, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00473720 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Satraplatin Paclitaxel |
Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |