BCX-1777 in Treating Patients With Refractory Cancer
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|ClinicalTrials.gov Identifier: NCT00073944|
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : May 30, 2013
RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: forodesine hydrochloride||Phase 1|
- Determine the maximum tolerated dose of BCX-1777 in patients with refractory T-cell or non-T-cell malignancies.
- Determine the safety and dose-limiting toxicity of this drug in these patients.
- Determine the pharmacokinetics of single oral and single and multiple IV doses of this drug in these patients.
- Determine the oral bioavailability of this drug in these patients.
- Determine, preliminarily, the antitumor activity of this drug in these patients.
OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.
- Courses 1 and 2: Patients receive oral BCX-1777 on days 1 and 15* and BCX-1777 IV over 30 minutes on days 8* and 22*.
- Course 3: Beginning approximately 6 days* after the completion of courses 1 and 2, patients receive BCX-1777 IV over 30 minutes once daily on days 1-5 and 8-12 (total of 10 doses).
NOTE: *+/- 1 day
Patients with stable disease or better and no dose-limiting toxicity (DLT) may receive an additional 10-dose treatment course (as in course 3) after a 10- to 16-day drug-free interval.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BCX-1777 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 DLT.
Patients are followed at 14 and 30 days.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||January 2005|
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): NCT00073944
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Alex Shalaurov, MD, PhD||Inveresk Research Group, Incorporated|