Btk Inhibitor Phase I Trial in B-cell Lymphoma -- PCYC-04753

Official Title

Phase I Dose-Escalation Study of Bruton ‘s Tyrosine Kinase (BTK) Inhibitor PCI-32765 in recurrent B-cell lymphoma

Purpose

The purpose of this study is to determine the highest dose of PCI-32765 that can be taken by month in oral capsule form without causing serious side effects in patients with recurrent B-cell lymphoma. The study will look at safety of the study drug and whether the treatment schedule is tolerated by patients.

Study Design

In the Phase 1 dose escalation study, cohorts of 4 to 6 patients will each receive PCI-32765 orally at doses starting at 1.25 mg/kg/ day and going up to 17.5 mg/kg/day administered daily for 28 days followed by 7 day rest period (one cycle) until the maximum tolerated dose is established. Patients may be treated for a maximum of 6 cycles.

Eligibility

• At least 18 years of age
• Body weight greater than 40 kg
• Confirm recurrent surface immunoglobulin positive B-cell Non-Hodgkin’s Lymphoma
• Bi-dimensional measurable disease
• Have failed greater than or equal to 1 previous treatments for lymphoma and no standard treatment is available
• Ability to swallow oral capsules without difficulty
• ECOG performance status ≤ 1
• Creatinine < 1.5 × institutional upper limit of normal (ULN)
• Total bilirubin < 1.5 × institutional ULN (unless elevated from documented Gilbert's syndrome)
• AST and ALT < 2.5 × institutional ULN
• Platelet count > 75000/µL
• ANC > 1500/µL
• Willing and able to sign a written informed consent

For more details about this study, please refer to information posted at http://www.clinicaltrials.gov or contact Pharmacyclics Medical Affairs by email at MedicalAffairs@pcyc.com or 1.408.774.0330.