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2003-04
2005-01
N/A
N/A
NCT00073944
National Cancer Institute (NCI)
National Cancer Institute (NCI)
INTERVENTIONAL
BCX-1777 in Treating Patients With Refractory Cancer
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.
OBJECTIVES: Primary * 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. Secondary * 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2003-12-10 | N/A | 2013-05-29 |
2003-12-10 | N/A | 2013-05-30 |
2003-12-11 | N/A | 2004-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
N/A
Interventional Model:
N/A
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
