Information obtained from ClinicalTrials.gov on May 22, 2013Link to the current ClinicalTrials.gov record.http://clinicaltrials.gov/show/NCT01149668PCYC-0405-CAPCI-24781NCT01149668A Safety and Tolerability Study of PCI-24781 in Subjects With CancerA Long-term Safety Study of the Pan-histone Deacetylase (HDAC) Inhibitor, PCI-24781, in Subjects With CancerPharmacyclicsIndustryPharmacyclicsUnited States: Food and Drug AdministrationNo
The purpose of this study is to determine the long-term (> 6 months) safety of PCI 24781 PO
in subjects with lymphoma.
An open-label, monotherapy, multicenter, extension study open to subjects who have derived
benefit from PCI 24781 PO for at least 6 months and want to continue receiving study drug.
Subjects enrolled in this study will receive PCI-24781 at the schedule and dosage from their
prior protocol. Treatment may be continued as long as there is no evidence of progressive
disease or unacceptable toxicity.
Active, not recruitingJune 2010April 2015Phase 1InterventionalAllocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: TreatmentSafety30 days after last dose of study drugYesfrequency, severity and relatedness of adverse eventsTumor Responsefrequency of tumor assessments done per standard of careNotumor response will be assessed per established response criteria. This study will capture time to disease progression and duration of response.1100LymphomaNon-Hodgkin's LymphomaHodgkin DiseaseMultiple MyelomaLeukemiaLymphocyticChronicPCI-24781ExperimentalDrugPCI-24781Subjects enrolled in this study will receive PCI-24781 administered orally at the schedule and dosage from their prior protocol.PCI-24781PCI-24781
Inclusion Criteria:
1. Men and women with cancer that did not progress while treated with PCI 24781 PO for
at least 6 months and who want to continue receiving study drug
2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
3. Agreement to use contraception during the study and for 30 days after the last dose
of study drug if sexually active and able to bear children
4. Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules without difficulty
5. Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (in accordance
with national and local subject privacy regulations)
Exclusion Criteria:
1. A life-threatening illness, medical condition or organ system dysfunction which, in
the investigator's opinion, could compromise the subject's safety, interfere with the
absorption or metabolism of oral PCI-24781, or put the study outcomes at undue risk
2. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
congestive heart failure, or myocardial infarction within 6 months of screening, or
any Class 3 or 4 cardiac disease as defined by the New York Heart Association
Functional Classification
3. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel or ulcerative colitis, symptomatic
inflammatory bowel disease, or partial or complete bowel obstruction
4. Immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to
prednisone > 20 mg/day) or experimental therapy (other than PCI-24781 PO) within 4
weeks before first dose of study drug
5. Concomitant use of medicines known to cause QT prolongation or torsades de points
(see Appendix 2)
6. Central nervous system involvement by lymphoma
7. Known history of Human Immunodeficiency Virus (HIV) or active infection with
Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active
systemic infection
8. Creatinine > 1.5 x institutional upper limit of normal (ULN); total bilirubin > 1.5 x
ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or
alanine aminotransferase (ALT) > 2.5 x ULN
9. Lactating or pregnant
Both18 YearsN/ANoLei Zhou, MDStudy DirectorPharmacyclicsUniv of California San Fransico Med CenterSan FransiscoCalifornia94143United StatesNorthwestern Univ. Med SchoolChicagoIllinois60611United StatesHorizon Oncology CenterLafayetteIndiana47905United StatesWashington Univ. School of MedicineSt. LouisMissouri63110United StatesUniv. of Nebraska Medical CenterOmahaNebraska68198United StatesNebraska Methodist HospitalOmahaNebraska68114United StatesSarah Cannon Research InstituteNashvilleTennessee37203United StatesUnited StatesOctober 2012October 22, 2012June 21, 2010SponsorPCI-24781LymphomaNon-Hodgkin'sHodgkin DiseaseMultiple MyelomaLeukemiaLymphocyticChronicYesNoNoHodgkin DiseaseLeukemiaLymphomaLymphoma, Non-HodgkinMultiple MyelomaNeoplasms, Plasma CellHistone Deacetylase Inhibitors