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| Sponsor: | Pharmacyclics |
|---|---|
| Information provided by: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT00562224 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms by Site Lymphoma, Non-Hodgkin Hodgkin Disease Multiple Myeloma Leukemia, Lymphocytic, Chronic |
Drug: PCI-24781 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Phase I Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PCI-24781 Administered Orally in Patients With Advanced Cancer |
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1: Experimental
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Martha Guerra, BA, RN | 408-215-3455 | mguerra@pcyc.com |
| Contact: Nancy Szakacs, BS, MBA | 408-774-3329 | nszakacs@pcyc.com |
| United States, California | |
| California Cancer Care | Recruiting |
| Greenbrae, California, United States, 94904 | |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| United States, Tennessee | |
| Sarah Cannon Research Institue | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Samir Undevia, MD | University of Chicago |
More Information
| Responsible Party: | Pharmacyclics ( Ahmed Hamdy, MD ) |
| Study ID Numbers: | PCYC-0402 |
| Study First Received: | November 19, 2007 |
| Last Updated: | May 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00562224 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
PCI-24781 Neoplasms by site Lymphoma, non-hodgkin |
Hodgkin disease Multiple myeloma Leukemia, lymphocytic, chronic |
|
Leukemia, Lymphoid Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Blood Protein Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders Multiple Myeloma Lymphatic Diseases Leukemia |
Neoplasms Hemorrhagic Disorders Neoplasms by Site Leukemia, Lymphocytic, Chronic, B-Cell Cardiovascular Diseases Leukemia, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Hodgkin Disease Lymphoma Neoplasms, Plasma Cell |