NCT00562224

Study of the Safety and Tolerability of Oral Capsule Form of PCI-24781 in Advanced Cancer Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the highest dose of study drug 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.

Conditions

• Neoplasms by Site
• Lymphoma, Non-hodgkin
• Hodgkin Disease
• Multiple Myeloma
• Leukemia, Lymphocytic, Chronic

Interventions

Type	Name	Description
DRUG	PCI-24781	Up to 7 cohorts will receive PCI-24781 orally at doses starting at 30 mg/m2 three times a day approximately 4 hours apart ("TID"), up to 90 mg/m2, administered 5 days/week during the first 21 days of each 28 day cycle until MTD is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 twice a day approximately 4 hours apart ("BID"). If a DLT occurs on the "BID" schedule, the subsequent cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle). If a DLT occurs on this dosing schedule, then the next cohort will receive PCI-24781 BID for 5 days/week every other week (2 times in a 28 day cycle) until the maximum tolerated dose is reached.

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-06-01
• Completion: 2010-09-01
• First posted: 2007-11-21
• Last updated: 2011-09-28

Locations

4 sites across 1 country: United States