Phase 2 Trial of the Histone Deacetylase (HDAC) Inhibitor PCI-24781 for Treatment of Lymphoma

Official Title

PCYC 0403: Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma (PCYC-0403)

Purpose

The first part of the study will determine the highest dose of study drug that can be taken without causing serious side effects in patients with lymphoma. The appropriate dose determined from the first part of the study will be used in the second part of the study to assess disease response in 6 different types of lymphoma patients.

Study Design

In the Phase 1 dose escalation study, up to 5 cohorts will receive PCI-24781 orally at doses starting at 30 mg/m2 twice a day (BID) approximately 4 - 6 hours apart, up to 90 mg/m2 BID, administered 5 days per week during the first 21 days of each 28 day cycle until the maximum tolerated dose (MTD) is exceeded, thus completing Phase 1. In the Phase 2 efficacy evaluation, all patients will receive PCI-24781 orally 5 days per week for 21 days of each 28 day cycle at the MTD determined in Phase 1.

Eligibility

• At least 18 years of age
• Measurable, histologically confirmed, and previously treated lymphoma in one of the following categories:
• Hodgkin's lymphoma
• Diffuse large B-cell lymphoma, or Grade 3 follicular NHL
• Indolent lymphoma (follicular NHL Grades 1 and 2, nodal marginal zone, splenic marginal zone, small lymphocytic, and MALT lymphomas)
• Mantle cell lymphoma
• CTCL (including Mycosis fungoides or Sézary syndrome)
• PTCL
• Ability to swallow oral capsules without difficulty
• Estimated life expectancy > 12 weeks
• ECOG performance status ≤ 1
• Willing and able to sign a written informed consent

For more details about this study, please refer to information posted at http://clinicaltrials.gov/ct2/show/NCT00724984?term=pci-24781&rank=1
or contact Pharmacyclics Medical Affairs by email at MedicalAffairs@pcyc.com or 1.408.774.0330.