BCX-1777 in Treating Patients With Refractory Cancer

Phase 1

Completed

• Conditions: Cancer

• Registration Number: NCT00073944
• Lead Sponsor: BioCryst Pharmaceuticals

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-12-10
• Study First Submitted QC: 2003-12-10
• Study First Posted: 2003-12-11
• Status Verified: 2004-07
• Primary Completion: 2005-01
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States