SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00004049|
Recruitment Status : Unknown
Verified May 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 3, 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 SR-45023A in treating patients who have locally advanced or metastatic solid tumors that have not responded to previous treatment.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: apomine||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally advanced or metastatic solid tumors. II. Determine the quantitative and qualitative toxic effects of SR-45023A in these patients. III. Assess the plasma and urine pharmacokinetics of SR-45023A and relate these to drug effects, if possible, in these patients. IV. Determine any preliminary antitumor activity of SR-45023A in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A weekly. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SR-45023A 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 toxicity. Patients are followed for up to 1 month.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Official Title:||A Phase I and Pharmacokinetic Study of SR-45023A Administered Once Every 7 Days|
|Study Start Date :||April 1999|
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): NCT00004049
|United States, Texas|
|Institute for Drug Development|
|San Antonio, Texas, United States, 78245-3217|
|Study Chair:||Kathleen Nolte||Genzyme, a Sanofi Company|