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 Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	Pharmaceutical / Industry	BIOCRYST-1777BC-101 CCF-5909, NCT00073944

Objectives

Primary

1. Determine the maximum tolerated dose of BCX-1777 in patients with refractory T-cell or non-T-cell malignancies.
2. Determine the safety and dose-limiting toxicity of this drug in these patients.

Secondary

1. Determine the pharmacokinetics of single oral and single and multiple IV doses of this drug in these patients.
2. Determine the oral bioavailability of this drug in these patients.
3. Determine, preliminarily, the antitumor activity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed diagnosis of 1 of the following:
  • Hematologic malignancy that is refractory to at least 1 prior curative treatment
  • Non-hematologic tumor that is refractory to at least 2 prior therapies, with or without measurable disease, including the following:
    • Gastrointestinal adenocarcinoma of 1 of the following sites:
      • Pancreatic
      • Biliary
      • Gastric
      • Colorectal
      • Esophageal
    • Melanoma
    • Ovarian cancer
    • Astrocytoma brain tumor



• Not immediately eligible for any other treatment that would be potentially curative or life-prolonging, in the opinion of the investigator
  • Patients who may be candidates for future bone marrow transplantation are eligible



• No brain metastases (other than astrocytomas)



• No clinically significant pleural effusion



• No complete tumor obstruction (e.g., bronchus, ureter, or bowel)

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Concurrent corticosteroids allowed provided the patient is on a stable regimen

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Recovered from prior therapy
  • No grade 2-4 toxicity
• More than 3 weeks since prior antineoplastic and/or investigational therapy
• No other concurrent systemic antineoplastic or investigational therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

  OR

• Karnofsky 50-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,500/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count greater than 50,000/mm³
• Hematocrit stable without the need for transfusion (epoetin alfa support allowed)

Hepatic

• Bilirubin less than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome)
• SGOT and SGPT less than 2 times ULN
• No active hepatitis B or C

Renal

• Creatinine clearance at least 50 mL/min

Cardiovascular

• No American Heart Association class III or IV cardiac disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No active systemic infection requiring IV antibiotics

Expected Enrollment

A total of 3-24 patients will be accrued for this study.

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.

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 Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies
Trial Start Date		2003-04-01
Trial Completion Date		2005-01-31
Registered in ClinicalTrials.gov		NCT00073944
Date Submitted to PDQ		2003-10-17
Information Last Verified		2004-07-26

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