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

NCT ID: NCT01149668

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-04-30

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCI-24781

Group Type: EXPERIMENTAL

PCI-24781

Intervention Type: DRUG

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

Interventions

PCI-24781

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacyclics LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thorsten Graef, MD

Role: STUDY_DIRECTOR

Pharmacyclics LLC.

Locations

Northwestern Univ. Med School

Chicago, Illinois, United States

Horizon Oncology Center

Lafayette, Indiana, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Univ. of Nebraska Medical Center

Omaha, Nebraska, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

PCI-24781

Identifier Type: REGISTRY

Identifier Source: secondary_id

PCYC-0405-CA

Identifier Type: -

Identifier Source: org_study_id