BMS-188797 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Treatment
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|ClinicalTrials.gov Identifier: NCT00005611|
Recruitment Status : Unknown
Verified August 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 26, 2004
Last Update Posted : July 24, 2008
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-188797 in treating patients who have advanced solid tumors that have not responded to previous treatment.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: BMS-188797||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose, dose limiting toxicities, and safety of BMS-188787 in patients with nonhematologic malignancies. II. Determine the plasma pharmacokinetics of BMS-188797 in these patients. III. Describe any antitumor activity of this treatment in these patients.
OUTLINE: This is a dose escalation study. Patients receive BMS-188797 IV over 1 hour. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-188797 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed every 4 weeks until toxicities resolve, and then at the investigator's discretion.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study over 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of BMS-188797 in Patients With Advanced Malignancies|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005611
|Study Chair:||William S. Dalton, MD, PhD||H. Lee Moffitt Cancer Center and Research Institute|