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A Long-term Safety Study of the Pan-histone Deacetylase (HDAC) Inhibitor, PCI-24781, in Subjects With Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin's Lymphoma, Hodgkin Disease, Multiple Myeloma, Leukemia, Lymphocytic

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Trial Information

A Long-term Safety Study of the Pan-histone Deacetylase (HDAC) Inhibitor, PCI-24781, in Subjects With Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

frequency, severity and relatedness of adverse events

Outcome Time Frame:

30 days after last dose of study drug

Safety Issue:

Yes

Principal Investigator

Thorsten Graef, MD

Investigator Role:

Study Director

Investigator Affiliation:

Pharmacyclics

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0405-CA

NCT ID:

NCT01149668

Start Date:

June 2010

Completion Date:

April 2013

Related Keywords:

  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • Hodgkin Disease
  • Multiple Myeloma
  • Leukemia
  • Lymphocytic
  • PCI-24781
  • Lymphoma
  • Non-Hodgkin's
  • Hodgkin Disease
  • Multiple Myeloma
  • Leukemia
  • Lymphocytic
  • Chronic
  • Hodgkin Disease
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Nebraska Methodist HospitalOmaha, Nebraska  68114
Sarah Cannon Research InstituteNashville, Tennessee  37203
Horizon Oncology CenterLafayette, Indiana  47905
Northwestern Univ. Med SchoolChicago, Illinois  60611
Univ. of Nebraska Medical CenterOmaha, Nebraska  68198