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

NCT01149668 | Completed Phase 1

• 2 other identifiers: PCYC-0405-CAPCI-24781
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Lymphoma; Non-Hodgkin's Lymphoma; Hodgkin Disease; Multiple Myeloma; Leukemia; Lymphocytic

Keywords

PCI-24781; Lymphoma; Non-Hodgkin's; Hodgkin Disease; Multiple Myeloma; Leukemia; Lymphocytic; Chronic

Outcome Measures

Primary Outcomes (1)

• Safety

  frequency, severity and relatedness of adverse events

  30 days after last dose of study drug

Secondary Outcomes (1)

• Tumor Response

  frequency of tumor assessments done per standard of care

Study Arms (1)

PCI-24781

EXPERIMENTAL

Drug: PCI-24781

Interventions

PCI-24781 DRUG

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

PCI-24781

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacyclics LLC.: lead

Study Sites (5)

Northwestern Univ. Med School

Chicago, Illinois, 60611, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Univ. of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Multiple Myeloma; Leukemia; Bronchiolitis Obliterans Syndrome

Interventions

abexinostat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Study Officials

• Thorsten Graef, MD

  Pharmacyclics LLC.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 23, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (5)