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Tracking Information | |||||||||
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First Received Date † | May 11, 2007 | ||||||||
Last Updated Date | December 2, 2008 | ||||||||
Start Date † | May 2007 | ||||||||
Current Primary Outcome Measures † |
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. [ Time Frame: Upon completion of dose escalation and determination of MTD ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00473720 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Phase I Study of the Combination of Satraplatin and Abraxane in Advanced Cancers | ||||||||
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 | ||||||||
Brief Summary | 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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Detailed Description | |||||||||
Study Phase | Phase I | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
Condition † | Advanced Cancers | ||||||||
Intervention † |
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Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 30 | ||||||||
Estimated Completion Date | December 2009 | ||||||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | 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:
Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated.
No concomitant use of the following drugs is allowed: cyclosporine, diltiazem, ketoconazole, rifampin, fluconazole, delavirdine, nicardipine, pioglitazone, and sulfonamides, St Johns Wort. Consumption of grapefruit juice is prohibited during the study. Patients will be asked as to which medicines (traditional or herbal) they are taking at every study visit. If possible, these medications and/or all herbal medicines should not be restarted until 72 hours after the last drug dose on study. |
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00473720 | ||||||||
Responsible Party | Hari Deshpande, M.D., Principal Investigator, Yale University School of Medicine | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Yale University | ||||||||
Collaborators †† | GPC Biotech | ||||||||
Investigators † |
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Information Provided By | Yale University | ||||||||
Verification Date | December 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |