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CompletedNCT01149668Updated Jun 19, 2013

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

A Phase 1 interventional study of PCI-24781 in Lymphoma, Non-Hodgkin's Lymphoma and Hodgkin Disease, sponsored by Pharmacyclics LLC.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-19.

Sponsored by Pharmacyclics LLC. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 7 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Pharmacyclics LLC. is the lead sponsor of 54 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    PCI-24781

    Drug: PCI-24781

Interventions

  • DrugPCI-24781

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

06

What researchers measure

Primary outcomes

  1. Safety

    frequency, severity and relatedness of adverse events

    Time frame: 30 days after last dose of study drug

Secondary outcomes

  1. Tumor Response

    tumor response will be assessed per established response criteria. This study will capture time to disease progression and duration of response.

    Time frame: frequency of tumor assessments done per standard of care

07

Study locations

5 sites
  • Northwestern Univ. Med School
    Chicago, Illinois 60611, United States
  • Horizon Oncology Center
    Lafayette, Indiana 47905, United States
  • Nebraska Methodist Hospital
    Omaha, Nebraska 68114, United States
  • Univ. of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01149668
Lead sponsor
Pharmacyclics LLC.
Responsible party
Sponsor
First posted
Jun 23, 2010
Start date
Jun 2010
Primary completion
Dec 2012
Completion
Apr 2013
Last update
Jun 19, 2013

Study contacts

Thorsten Graef, MD
study director · Pharmacyclics LLC.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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