BCX-1777 in Treating Patients With Refractory Cancer

Cancer Clinical Trial

Official title:

Phase I Pharmacology Study Of Oral And Intravenous BCX-1777 In Patients With Refractory T-Cell And Non-T-Cell Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073944
• Other study ID #: BIOCRYST-1777BC-101
• Secondary ID: CDR0000341332CCF
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2003
• Last updated: May 29, 2013
• Start date: April 2003

Study information

• Verified date: July 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• forodesine hydrochloride

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Country where clinical trial is conducted

United States,