A Phase 1 interventional study of PCI-24781 in Neoplasms by Site, Lymphoma, Non-hodgkin and Hodgkin Disease, sponsored by Pharmacyclics LLC.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-28.
Sponsored by Pharmacyclics LLC. · Phase 1, Interventional, and Treatment
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 36 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Pharmacyclics LLC. is the lead sponsor of 54 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All study subjects will receive PCI-24781 (study drug).
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.
Dose limiting toxicity assessment at the end of the first 28 day cycle.
Time frame: at the end of the first 28 day cycle
Measure: Adverse event assessed through 30 days after last dose of study drug Measure: Tumor response Measure: Pharmacokinetic/Pharmacodynamic assessments
Time frame: AE through 30 days after last dose of study drug, Tumor response at the end of every 2nd 28 day cycle, PK/PD assessments on Day 1, 2, 3 (or 4 or 5), and Day 8 of cycle 1
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Pharmacyclics LLC.