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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
GPC Biotech |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00473720 |
Purpose
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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Hari Deshpande, M.D., Principal Investigator, Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00473720 History of Changes |
| Other Study ID Numbers: | 0606001535 |
| Study First Received: | May 11, 2007 |
| Last Updated: | June 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms Paclitaxel Satraplatin Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |