Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00562224 | Study of the Safety and Tolerability of Oral Capsule Form of PCI-24781 in Advanced Cancer Patients | PHASE1 | COMPLETED | 36 | — | — | Nov 1, 2007 | Sep 1, 2010 | Sep 28, 2011 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | All study subjects will receive PCI-24781 (study drug). |
| Name | Type | Description |
|---|---|---|
| PCI-24781 | DRUG | 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. |
Inclusion Criteria: * age ≥ 18 years * 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 w...