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

• Sponsor: Pharmacyclics LLC. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01149668
• Collaborator: (none)
• Enrollment: 7
• Locations: 5
• Arm: 1
• Duration (Months): 34
• Patients Per Site: 1.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma; Non-Hodgkin's Lymphoma; Hodgkin Disease; Multiple Myeloma; Leukemia; Lymphocytic	Drug: PCI-24781	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-term Safety Study of the Pan-histone Deacetylase (HDAC) Inhibitor, PCI-24781, in Subjects With Cancer
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PCI-24781	Drug: PCI-24781; Subjects enrolled in this study will receive PCI-24781 administered orally at the schedule and dosage from their prior protocol.

Outcome Measures

Primary Outcome Measures

1. Safety [30 days after last dose of study drug]

   frequency, severity and relatedness of adverse events

Secondary Outcome Measures

1. Tumor Response [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Univ. Med School	Chicago	Illinois	United States	60611
2	Horizon Oncology Center	Lafayette	Indiana	United States	47905
3	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
4	Univ. of Nebraska Medical Center	Omaha	Nebraska	United States	68198
5	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Pharmacyclics LLC.

Investigators

• Study Director: Thorsten Graef, MD, Pharmacyclics LLC.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pharmacyclics LLC.
• ClinicalTrials.gov Identifier: NCT01149668
• Other Study ID Numbers: PCYC-0405-CA; PCI-24781
• First Posted: Jun 23, 2010
• Last Update Posted: Jun 19, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Pharmacyclics LLC.: PCI-24781; Lymphoma; Non-Hodgkin's; Hodgkin Disease; Multiple Myeloma; Leukemia; Lymphocytic; Chronic
• Additional relevant MeSH terms: Lymphoma; Multiple Myeloma; Hodgkin Disease; Abexinostat

Study Results

No Results Posted as of Jun 19, 2013