A Safety and Tolerability Study of PCI-24781 in Subjects With Cancer

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149668
• Other study ID #: PCYC-0405-CA
• Secondary ID: PCI-24781
• Status: Completed
• Phase: Phase 1
• First received: June 21, 2010
• Last updated: June 17, 2013
• Start date: June 2010
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Pharmacyclics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the long-term (> 6 months) safety of PCI 24781 PO in subjects with lymphoma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• PCI-24781
Subjects enrolled in this study will receive PCI-24781 administered orally at the schedule and dosage from their prior protocol.

Locations

Country	Name	City	State
United States	Northwestern Univ. Med School	Chicago	Illinois
United States	Horizon Oncology Center	Lafayette	Indiana
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Univ. of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	frequency, severity and relatedness of adverse events	30 days after last dose of study drug	Yes
Secondary	Tumor Response	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	No