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Open Label, Dose Escalation Trial of Oral PXD101 in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Solid Tumor, Lymphoma

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Trial Information

Open Label, Dose Escalation Trial of Oral PXD101 in Patients With Advanced Solid Tumors

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
Hodgkin's disease (NK-cell = natural killer cell)

- 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) (AST=aspartate aminotransferase, ALT=alanine aminotransferase)

- serum creatinine ≤ 1.5 x ULN

- PT-INR/PTT ≤ 1.5 x ULN, or for patients on anticoagulation therapy, status
within therapeutic range (PT-INR/PTT = prothrombin-international normalized
ratio/prothrombin time)

- 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

- AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN is acceptable if liver has tumor

- serum creatinine ≤ 1.5 x ULN

- PT-INR/PTT ≤ 1.5 x ULN, or in the therapeutic range if on anticoagulation

- 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

- 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

- 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 (QTc=corrected QT interval)

- Long QT syndrome

- required use of concomitant medication on dosing days that may cause torsade de

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort

Outcome Time Frame:

throughout the study

Safety Issue:


Principal Investigator

William Kevin Kelly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

August 2011

Related Keywords:

  • Solid Tumor
  • Lymphoma
  • 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
  • thyroid cancer
  • PXD101
  • Lymphoma
  • Neoplasms



M.D. Anderson Cancer Center Houston, Texas  77030
Yale New Haven Hospital New Haven, Connecticut  06520
Columbia University - Herbert Irving Cancer Center New York, New York  01132
New York University Cancer Institute New York, New York  10016