Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

BCX-1777 in Treating Patients With Refractory Hematologic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	16 and over	Pharmaceutical / Industry	BIOCRYST-1777BC-102 NCT00066235

Objectives

1. Determine the maximum tolerated dose of BCX-1777 in patients with refractory hematologic malignancies.
2. Determine the safety profile of this drug in these patients.
3. Determine the pharmacokinetics of this drug in these patients.
4. Determine, preliminarily, the efficacy of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven hematologic malignancy



• Refractory disease for which no better treatment is available



• Measurable (e.g., at least 1 lymph node at least 1.5 cm in diameter) or evaluable (e.g., acute leukemia) disease



• No cutaneous T-cell lymphoma



• Not a candidate for stem cell transplantation



• No CNS leukemia or lymphoma requiring intrathecal therapy or craniospinal radiotherapy

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• No concurrent antibody therapy
• No concurrent immunotherapy
• No concurrent vaccine therapy
• No concurrent angiogenesis inhibitor therapy
• No concurrent sargramostim (GM-CSF)
• No concurrent gene therapy

Chemotherapy

• More than 7 days since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy
• Concurrent stable-dose steroid therapy allowed

Radiotherapy

• See Disease Characteristics
• No concurrent radiotherapy

Surgery

• Not specified

Other

• More than 7 days since prior investigational antileukemic agents
• No packed red blood cell or platelet transfusion or any other citrate-containing blood products within 30 minutes before or after study drug
• No other concurrent anticancer or experimental agents
• No concurrent matrix metalloprotease inhibitors

Patient Characteristics:

Age

• 16 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Platelet count at least 50,000/mm³
• Neutrophil count at least 1,000/mm³ (except for patients with acute leukemia or in the acute leukemic phase of a hematologic malignancy)

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome)
• AST and ALT no greater than 2 times ULN
• No chronic symptomatic or asymptomatic infection due to hepatitis B or C

Renal

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance at least 60 mL/min

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No concurrent active serious infection not controlled by oral or IV antibiotics

Expected Enrollment

A total of 12-24 patients will be accrued for this study.

Outline

This is an open-label, non-randomized, dose-escalation, multicenter study.

Patients receive BCX-1777 IV over 30 minutes once on day 1 and twice daily on days 2-5. Treatment repeats every 21 days for a total of 2 courses 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 6 patients experience dose-limiting toxicity.

Patients are followed at 14 and 30 days.

Trial Contact Information

Trial Lead Organizations

BioCryst Pharmaceuticals, Incorporated

Alex Shalaurov, MD, PhD, Protocol chair		Ph: 919-462-2274

Registry Information
Official Title		Phase I Multi-Center Study of Intravenous BCX-1777 in Patients with Refractory Hematologic Malignancies
Registered in ClinicalTrials.gov		NCT00066235
Date Submitted to PDQ		2003-03-14
Information Last Verified		2004-08-05

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