- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01149668
A Safety and Tolerability Study of PCI-24781 in Subjects With Cancer
A Long-term Safety Study of the Pan-histone Deacetylase (HDAC) Inhibitor, PCI-24781, in Subjects With Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Univ. Med School
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Indiana
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Lafayette, Indiana, United States, 47905
- Horizon Oncology Center
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska Methodist Hospital
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Omaha, Nebraska, United States, 68198
- Univ. of Nebraska Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- 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
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
- 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:
- 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
- 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
- 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
- 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
- Concomitant use of medicines known to cause QT prolongation or torsades de points (see Appendix 2)
- Central nervous system involvement by lymphoma
- 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
- 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
- Lactating or pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PCI-24781
|
Subjects enrolled in this study will receive PCI-24781 administered orally at the schedule and dosage from their prior protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 30 days after last dose of study drug
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frequency, severity and relatedness of adverse events
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30 days after last dose of study drug
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Response
Time Frame: frequency of tumor assessments done per standard of care
|
tumor response will be assessed per established response criteria.
This study will capture time to disease progression and duration of response.
|
frequency of tumor assessments done per standard of care
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Thorsten Graef, MD, Pharmacyclics LLC.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Lymphoma
- Multiple Myeloma
- Hodgkin Disease
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Histone Deacetylase Inhibitors
- Abexinostat
Other Study ID Numbers
- PCYC-0405-CA
- PCI-24781 (Registry Identifier: 69451)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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