Study PCYC-402

Phase 1 Trial of the Safety and Tolerability of Oral Capsule Form of PCI-24781 in Advanced Cancer Patients

Official Title

Phase I Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PCI-24781 Administered Orally in Patients With Advanced Cancer

Purpose

This study seeks to determine the highest dose of PCI-24781 that can be taken without causing serious side effects in patients with advanced cancer. 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, up to 5 cohorts will receive PCI-24781 orally at doses starting at 30 mg/m2 three times a day, approximately 4 hours apart (commonly referred to as “TID"), up to 150 mg/m2 TID, administered 5 days per week during the first 21 days of each 28 day cycle until the maximum tolerated dose is reached. An additional cohort (Dose Expansion Cohort) will receive PCI-24781 orally TID, 5 days per week for 28 days of each 28-day cycle at the maximum tolerated dose, determined from the 21 day administration schedule cohorts

Eligibility

  • At least 18 years of age
  • Histologically confirmed, measurable solid tumor, non-Hodgkin's lymphoma, Hodgkin's disease, chronic lymphocytic leukemia, or multiple myeloma that has relapsed after standard therapy or for which no standard therapy exists
  • Ability to swallow oral capsules without difficulty
  • Estimated life expectancy > 12 weeks
  • ECOG performance status ≤ 2
  • 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 (≤ 5 × institutional ULN in the presence of liver metastases)
  • Platelet count ≥ 100,000/µL
  • ANC ≥ 1500/µL
  • Hgb ≥ 9.0 g/dL
  • Patients with previously treated, stable, asymptomatic brain metastases who are not on corticosteroids are eligible
  • 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/NCT00562224?term=pci-24781&rank=2
or contact Pharmacyclics Medical Affairs by email at MedicalAffairs@pcyc.com or 1.408.774.0330.