BCX-1777 in Treating Patients With Refractory Cancer

May 29, 2013 updated by: BioCryst Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioCryst Pharmaceuticals

Investigators

  • Study Chair: Alex Shalaurov, MD, PhD, Inveresk Research Group, Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

December 10, 2003

First Submitted That Met QC Criteria

December 10, 2003

First Posted (Estimate)

December 11, 2003

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

July 1, 2004

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BIOCRYST-1777BC-101
  • CDR0000341332 (Registry Identifier: PDQ (Physician Data Query))
  • CCF-5909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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