BCX-1777 in Treating Patients With Refractory Cancer

NCT ID: NCT00073944

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30

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.

Conditions

Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

forodesine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

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/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count greater than 50,000/mm^3
• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Alex Shalaurov, MD, PhD

Role: STUDY_CHAIR

Inveresk Research Group, Incorporated

Locations

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CDR0000341332

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCF-5909

Identifier Type: -

Identifier Source: secondary_id

BIOCRYST-1777BC-101

Identifier Type: -

Identifier Source: org_study_id