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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Bristol-Myers Squibb | INDUSTRY |
Iso-fludelone is a type of chemotherapy drug called an epothilone. Epothilones are drugs that attach to proteins in your body called "tubulins". Tubulins help cells to grow, and are found in both normal and cancer cells. When research animals with cancer were given the study drug, Iso-fludelone, the drug attached itself to "tubulin" and slowed or stopped the cancer cells from growing. Other types of epothilones have been tested in cancer patients and were found to be safe. A similar epothilone drug and other drugs called taxanes are currently approved by the FDA for treating certain types of cancers.
The purpose of this study is to see the effects, good and/or bad, of this investigational drug, Iso-fludelone, on cancer. The term "investigational" means the study drug being tested has not been approved by the United States Food and Drug Administration (FDA) or other regulatory agencies. This study is the first time the investigators are using iso-fludelone in people. This is a Phase I study. In a Phase I study, the first people to receive the drug are given a fairly low dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Advanced Solid Tumors | Experimental | The trial was initially designed as a 3 hour IV infusion of iso-fludelone every 3 weeks with three dose-escalation stages (12 patients), however it has been amended to study iso-fludelone administered over 6 hours (+/- 30 minutes) every 3 weeks schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iso-Fludelone | Drug | Iso-fludelone will be administered IV over 6 hours (+/- 30 mins) on Day 1 of every 3 week cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose (MTD) | The MTD is defined as the dose that results in DLT in 25% of all evaluable patients. | 2 years |
| To determine the dose limiting toxicity (DLT), safety | Toxicities and adverse events will be assessed using the NCI CTC version 4.0 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the plasma pharmacokinetics of iso-fludelone when administered intravenously | All PK analyses will be performed using the WinNonlin computer program; version 5.3 Pharsight Corporation, Mountain View, CA). PK Model selection will be based on a visual inspection of goodness of fit plots (observations vs. predictions, residuals and weighted residuals vs. predictions). The assay values (concentrations vs times) will be used to calculate individual-specific elimination rate constant (Ke), time to maximum Iso-fludelone concentration (Tmax), maximum Iso-fludelone concentration (Cmax) and area under the concentration-time curve (AUC) values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mrinal Gounder, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25168219 | Derived | Christner SM, Parise RA, Levine ED, Rizvi NA, Gounder MM, Beumer JH. Quantitative method for the determination of iso-fludelone (KOS-1803) in human plasma by LC-MS/MS. J Pharm Biomed Anal. 2014 Nov;100:199-204. doi: 10.1016/j.jpba.2014.08.007. Epub 2014 Aug 12. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| over 6 hours (+/- 30 minutes) on a day 1 every 21 days schedule |
| To describe and assess any preliminary evidence of anti-tumor activity of iso-fludelone | every 6 weeks |