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BCX-1777 in Treating Patients With Refractory Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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) 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00073944
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 BioCryst Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alex Shalaurov, MD, PhD
Principal Investigator Affiliation Inveresk Research Group, Incorporated
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cancer
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195

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