Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005807
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2000-06-02
Brief Title:
Treating Patients With Advanced Solid Tumors Breast Cancer or Recurrent Ovarian Cancer
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
A Phase I Scientific Exploratory Study of Epothilone B Analog in Patients With Solid Tumors and Gynecological Malignancies
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BMS-247550
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of BMS-247550 in treating patients who have metastatic recurrent or locally advanced ovarian cancer breast cancer or metastatic or unresectable solid tumors
PURPOSE Phase I trial to study the effectiveness of BMS-247550 in treating patients who have metastatic recurrent or locally advanced ovarian cancer breast cancer or metastatic or unresectable solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose recommended phase II dose and associated toxic effects of BMS-247550 in patients with advanced solid tumors
Determine the pharmacokinetic and pharmacodynamic relationship of this treatment regimen in these patients
Assess the extent of microtubule bundle and mitotic aster formation and cell cycle kinetics in peripheral blood mononuclear cells in these patients treated with this regimen
Determine any evidence of antitumor activity of this treatment regimen in these patients
Evaluate the relationship between tumor response and the occurrence of mutation in the class 1 isotype of B-tubulin and B-tubulin isotype distribution in patients with advanced or recurrent solid tumors ovarian cancer or breast cancer treated with this regimen
Investigate Multi-Drug Resistance Gene MDR1 Multidrug Resistance-associated Protein MRP Gene and canalicular multispecific organic anion transporter 1cMOAT messenger ribonucleic acid mRNA and protein expression as prognosticators of tumor response in these patients treated with this regimen
Determine the relationship between stathmin expression and phosphorylation status as a function of response in these patients treated with this regimen
Correlate the expression of proapoptotic p53 bax bad and bid and antiapoptotic survivin inhibitors of apoptotic proteins bcl-2 and bcl-x proteins in tumor samples andor ascites with response and clinical outcome in these patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Part I Patients with advanced solid tumors receive BMS-247550 IV over 1 hour every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Part II Patients with ovarian breast or other cancer receive BMS-247550 as in the part I portion of the study at the MTD Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed at 2 months
PROJECTED ACCRUAL Approximately 42-66 patients will be accrued for this study within 12-16 months
Determine the maximum tolerated dose recommended phase II dose and associated toxic effects of BMS-247550 in patients with advanced solid tumors
Determine the pharmacokinetic and pharmacodynamic relationship of this treatment regimen in these patients
Assess the extent of microtubule bundle and mitotic aster formation and cell cycle kinetics in peripheral blood mononuclear cells in these patients treated with this regimen
Determine any evidence of antitumor activity of this treatment regimen in these patients
Evaluate the relationship between tumor response and the occurrence of mutation in the class 1 isotype of B-tubulin and B-tubulin isotype distribution in patients with advanced or recurrent solid tumors ovarian cancer or breast cancer treated with this regimen
Investigate Multi-Drug Resistance Gene MDR1 Multidrug Resistance-associated Protein MRP Gene and canalicular multispecific organic anion transporter 1cMOAT messenger ribonucleic acid mRNA and protein expression as prognosticators of tumor response in these patients treated with this regimen
Determine the relationship between stathmin expression and phosphorylation status as a function of response in these patients treated with this regimen
Correlate the expression of proapoptotic p53 bax bad and bid and antiapoptotic survivin inhibitors of apoptotic proteins bcl-2 and bcl-x proteins in tumor samples andor ascites with response and clinical outcome in these patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Part I Patients with advanced solid tumors receive BMS-247550 IV over 1 hour every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Part II Patients with ovarian breast or other cancer receive BMS-247550 as in the part I portion of the study at the MTD Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed at 2 months
PROJECTED ACCRUAL Approximately 42-66 patients will be accrued for this study within 12-16 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NYU-0006 | None | None | None |
| AECM-9911378 | None | None | None |
| NCI-98 | None | None | None |