KRN5500 in Treating Patients With Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00002923|
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : April 25, 2014
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 evaluate the effectiveness of KRN5500 in treating patients with metastatic solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: KRN5500||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose and toxicities of KRN5500 in patients with solid malignant tumors. II. Characterize the clinical pharmacokinetics of KRN5500 in this patient population. III. Initiate the preliminary evaluation of antitumor activity of KRN5500 in these patients. IV. Determine the recommended Phase II dose of KRN5500.
OUTLINE: This is a dose escalation study. Patients receive KRN5500 IV over 1 hour on days 1-3. Courses repeat every 21 days. Patients with stable disease and partial or complete remission continue treatment for 6 months beyond complete remission. Cohorts of 3 to 6 patients receive escalating doses of KRN5500. The maximum tolerated dose is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study over 9-12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Evaluation of KRN5500 (NSC650426)|
|Study Start Date :||May 1997|
|Primary Completion Date :||January 2000|
|Study Completion Date :||October 2000|
|Experimental: KRN5500||Drug: KRN5500|
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): NCT00002923
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Study Chair:||Patricia M. LoRusso, DO||Barbara Ann Karmanos Cancer Institute|