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

Completed · Phase 1

Conditions studied: Solid Tumor, Lymphoma

In brief

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.

Key facts

Study ID

NCT00413075

Run by

Valerio Therapeutics

People needed

121

Starts

2006-06-01

Expected to finish

2011-08-01

Last updated by the study team

2015-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who meet any of the following criteria are not eligible to enroll in this trial:
• Prior treatment with PXD101
• Solid Tumor: Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea) Lymphoma: No anticancer therapy within 2 weeks except for Rituximab which patients should be off for greater than three months unless there is evidence of disease progression.
• Lymphoma patients who have relapsed within 100 days of autologous or allogeneic transplantation.
• Serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
• Presence of metastatic disease that, in the opinion of the investigator, would require palliative treatment within 4 weeks of enrollment
• Symptomatic brain metastases
• Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure (NYHA Class III or IV) related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry
• A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500 msec; Long QT Syndrome; the required use of concomitant medication on PXD101 dosing days that may cause Torsade de Pointes (See Section 11.7)
• Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
• Pregnant or breast-feeding women
• Men and women of childbearing age and potential, who are not willing to use effective contraception
• Major surgery within the last 4 weeks
• Known HIV positivity, as safety in this patient population has not been assessed.

Where it is running

• Yale New Haven Hospital — New Haven, Connecticut, United States
• Columbia University - Herbert Irving Cancer Center — New York, New York, United States
• New York University Cancer Institute — New York, New York, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States
• Research Facility — Copenhagen, Copenhagen, Denmark
• Research Facility — London, Surrey, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.