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Study of Oral PXD101 in Patients With Advanced Solid Tumors or Lymphoma

This study is currently recruiting participants.
Verified by TopoTarget A/S, June 2008

Sponsored by: TopoTarget A/S
Information provided by: TopoTarget A/S
ClinicalTrials.gov Identifier: NCT00413075
  Purpose

This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will be given once or twice daily at various dosing schedules to patients with solid tumors. Doses will be escalated until the maximum tolerated dose (MTD) is identified. In parallel, a cohort of lymphoma patients will be given oral belinostat on a discontinuous once daily dosing schedule.


Condition Intervention Phase
Solid Tumor
Lymphoma
Drug: belinostat
Phase I

Genetics Home Reference related topics:   bladder cancer    breast cancer   

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Parathyroid    Thyroid    Belinostat   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:   Open Label, Dose Escalation Trial of Oral PXD101 in Patients With Advanced Solid Tumors

Further study details as provided by TopoTarget A/S:

Primary Outcome Measures:
  • Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the pharmacokinetics of oral PXD101 when dosed once or twice daily at various dose levels [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Explore anti-tumor activity [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Determine the safety, tolerability, and anti-tumor activity of orally administered PXD101 to patients with lymphoma [ Time Frame: throughout the trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   100
Study Start Date:   July 2006
Estimated Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: belinostat
    oral belinostat dosed once or twice daily at continuous and discontinuous dosing schedules.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Solid tumor: Histologically confirmed solid tumors.
  • Lymphoma: relapsed or refractory B-cell or T-cell lymphoma, NK-cell lymphoma or Hodgkins disease
  • At least one evaluable lesion. Lesions must be evaluated by computed tomography (CT), magnetic resonance imaging (MRI), or bone scan. Patients with prostate cancer, bone disease and rising prostate-specific antigen [PSA] but no other evaluable disease are eligible and will be evaluated based on PSA. For lymphoma patients, lesions can also be measured by PET and/or evaluated in peripheral blood or bone marrow.
  • Progressive disease: Progressive disease will be defined as new or progressive lesions on CT-scan, MRI, bone scan or by rising PSA
  • ≥ 4 weeks since prior radiation therapy or chemotherapy
  • Karnofsky performance ≥ 60%
  • Solid Tumor: Acceptable liver, renal and bone marrow function to include:

    • absolute neutrophil count ≥ 1.5 x 10^9/L
    • hemoglobin ≥ 9.0 g/dl
    • platelets ≥ 100 x 10^9/L
    • bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN is acceptable if liver has tumor involvement)
    • serum creatinine ≤ 1.5 x ULN
    • PT-INR/PTT ≤ 1.5 x ULN, or for patients on anticoagulation therapy, status within therapeutic range
  • Lymphoma: Acceptable liver, renal and bone marrow function including the following:

    • absolute neutrophil count ≥ 1.0 x 10^9/L
    • platelets ≥ 50 x 10^9/L
    • bilirubin ≤ 1.5 x upper limit of normal (ULN), or ≤3 times ULN if documented hepatic involvement with lymphoma, or ≤5 times ULN if history of Gilbert's disease
    • AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN is acceptable if liver has tumor involvement)
    • serum creatinine ≤ 1.5 x ULN
    • PT-INR/PTT ≤ 1.5 x ULN, or in the therapeutic range if on anticoagulation therapy
  • Serum potassium within normal range
  • Estimated life expectancy of greater than 3 months
  • Signed informed consent prior to any study specific procedures

Exclusion Criteria:

  • Prior treatment with PXD101
  • Within 4 weeks of enrollment:

    • major surgery
    • metastatic disease requiring palliative treatment
    • Anticancer therapy, including:

      • chemotherapy
      • radiotherapy
      • endocrine therapy
      • immunotherapy
      • other investigational agents (6 weeks for mitomycin or nitrosourea)
      • Lymphoma patients: No anticancer therapy within 2 weeks except for Rituximab which patients should be off for greater than 3 months unless there is evidence of disease progression.
  • Serious concomitant systemic disorders (eg, active infection) compromising patient safety.
  • Symptomatic brain metastases
  • Significant cardiovascular disease, including:

    • unstable angina pectoris
    • uncontrolled hypertension
    • congestive heart failure (New York Heart Association [NYHA] Class III or IV) related to primary cardiac disease, a condition requiring anti-arrhythmic therapy
    • ischemic or severe valvular heart disease
    • myocardial infarction within 6 months prior to the trial entry
  • A marked baseline prolongation of QT/QTc interval, such as:

    • repeated demonstration of a QTc interval > 500 msec
    • Long QT syndrome
    • required use of concomitant medication on dosing days that may cause torsade de pointes
  • Altered mental status precluding understanding of the informed consent process and/or completion of the study
  • Pregnant or breast-feeding women
  • Refusal or inability to use effective means of contraception (for men and women of childbearing potential)
  • History of, or test positive for, HIV.
  • Lymphoma patients who have relapsed within 100 days of autologous or allogenic transplantation.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413075

Contacts
Contact: Karen Moeller, RN, Clinical Trial Manager     kam@topotarget.com    
Contact: Lisbet Skinnes, RN, Head Clin Operations     lsk@topotarget.com    

Locations
United States, Connecticut
Yale New Haven Hospital     Recruiting
      New Haven, Connecticut, United States, 06520
      Principal Investigator: Kevin Kelly, D.O.            
United States, New York
Columbia University - Herbert Irving Cancer Center     Recruiting
      New York, New York, United States, 01132
      Principal Investigator: Dan Petrylak, M.D.            
United States, Texas
M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77230-1402
      Principal Investigator: George Blumenschein, Jr, M.D.            
Denmark
Research Facility     Recruiting
      Copenhagen, Denmark
United Kingdom, Surrey
Research Facility     Recruiting
      London, Surrey, United Kingdom, SW3 6JJ

Sponsors and Collaborators
TopoTarget A/S
  More Information


Responsible Party:   TopoTarget A/S ( Jan Fagerberg/Medical Director )
Study ID Numbers:   PXD101-CLN-9
First Received:   December 18, 2006
Last Updated:   June 4, 2008
ClinicalTrials.gov Identifier:   NCT00413075
Health Authority:   United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Denmark: Danish Medicines Agency

Keywords provided by TopoTarget A/S:
Solid tumors  
Adenosarcoma  
B-cell lymphoma  
belinostat  
bladder cancer  
Breast cancer  
Carcinoma, Non-Small-Cell Lung  
Carcinoma, Small Cell  
Chondrosarcoma  
colorectal cancer  
Esophageal Neoplasms  
Fibrosarcoma  
head and neck cancer  
Hemangiosarcoma  
Hodgkins Disease  
kidney cancer
Leiomyosarcoma
Liposarcoma
lung cancer
lymphoma
mesothelioma
mesothelioma, cystic
Mixed Tumor, Mesodermal
Osteosarcoma
Otorhinolaryngologic Neoplasms
Ovarian cancer
Parathyroid Neoplasms
Prostate cancer
sarcoma
T-cell lymphoma

Study placed in the following topic categories:
Fibrosarcoma
Hodgkin's disease
Otorhinolaryngologic Neoplasms
Leiomyosarcoma
Hodgkin lymphoma, adult
Malignant mesenchymal tumor
Esophageal Neoplasms
Kidney cancer
Osteogenic sarcoma
Soft tissue sarcomas
Lymphoma, B-Cell
Lung Neoplasms
Kidney Neoplasms
Lymphoma, T-Cell
Chondrosarcoma
Esophageal neoplasm
Hodgkin Disease
Lymphoma
Bladder neoplasm
Ovarian cancer
Immunoproliferative Disorders
Ovarian Neoplasms
Esophageal disorder
Thyroid Neoplasms
Urinary Bladder Neoplasms
Breast Neoplasms
Osteosarcoma
Renal cancer
Hemangiosarcoma
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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