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CompletedNCT00562224Updated Sep 28, 2011

Study of the Safety and Tolerability of Oral Capsule Form of PCI-24781 in Advanced Cancer Patients

A Phase 1 interventional study of PCI-24781 in Neoplasms by Site, Lymphoma, Non-hodgkin and Hodgkin Disease, sponsored by Pharmacyclics LLC.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-28.

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

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

To determine the highest dose of study drug that can be taken without causing serious side effects in patients with advanced cancer. The study will look at safety of the study drug and whether the treatment schedule is tolerated by patients.

02

Conditions studied

  • Neoplasms by Site
  • Lymphoma, Non-hodgkin
  • Hodgkin Disease
  • Multiple Myeloma
  • Leukemia, Lymphocytic, Chronic

Keywords

  • PCI-24781
  • Neoplasms by site
  • Lymphoma, non-hodgkin
  • Hodgkin disease
  • Multiple myeloma
  • Leukemia, lymphocytic, chronic
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 36 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma 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

  • age ≥ 18 years
  • Histologically confirmed, measurable solid tumor, non-Hodgkin's lymphoma, Hodgkin's disease, chronic lymphocytic leukemia, or multiple myeloma that has relapsed after standard therapy or for which no standard therapy exists
  • Ability to swallow oral capsules without difficulty
  • Estimated life expectancy > 12 weeks
  • ECOG performance status ≤ 2
  • Creatinine ≤ 1.5 × institutional upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 × institutional ULN (unless elevated from documented Gilbert's syndrome)
  • AST and ALT ≤ 2.5 × institutional ULN (≤ 5 × institutional ULN in the presence of liver metastases)
  • Platelet count ≥ 100,000/µL
  • ANC ≥ 1500/µL
  • Hgb ≥ 9.0 g/dL
  • Patients with previously treated, stable, asymptomatic brain metastases who are not on corticosteroids are eligible
  • Willing and able to sign a written informed consent-

Exclusion criteria

Exclusion Criteria:

  • Patients who have had immunotherapy, chemotherapy, or radiotherapy within 4 weeks (within 6 weeks for nitrosoureas or mitomycin C) prior to first day of drug dosing
  • Patients who have undergone major surgery within 4 weeks prior to first day of drug dosing
  • Patients who have received another investigational drug within 4 weeks
  • Evidence of leptomeningeal metastasis
  • Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of the oral drugs (eg, WDHA syndrome, carcinoid syndromes, diarrhea due to infections, malabsorption syndromes secondary to surgery or chemotherapy)
  • Uncontrolled illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
  • Patients with risk factors for, or who are receiving medications known to prolong QTc interval and that may be associated with Torsades de Pointes
  • QTc prolongation (defined as a QTc interval ≥ 450 msecs) or other significant ECG abnormalities including 2nd degree AV block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within the past 6 months.
  • Patients with known HIV infection
  • Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)
05

Study design

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

Study arms

  • Experimental
    Arm 1

    All study subjects will receive PCI-24781 (study drug).

    Drug: PCI-24781

Interventions

  • DrugPCI-24781

    Up to 7 cohorts will receive PCI-24781 orally at doses starting at 30 mg/m2 three times a day approximately 4 hours apart ("TID"), up to 90 mg/m2, administered 5 days/week during the first 21 days of each 28 day cycle until MTD is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 twice a day approximately 4 hours apart ("BID"). If a DLT occurs on the "BID" schedule, the subsequent cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle). If a DLT occurs on this dosing schedule, then the next cohort will receive PCI-24781 BID for 5 days/week every other week (2 times in a 28 day cycle) until the maximum tolerated dose is reached.

06

What researchers measure

Primary outcomes

  1. Dose limiting toxicity assessment at the end of the first 28 day cycle.

    Time frame: at the end of the first 28 day cycle

Secondary outcomes

  1. Measure: Adverse event assessed through 30 days after last dose of study drug Measure: Tumor response Measure: Pharmacokinetic/Pharmacodynamic assessments

    Time frame: AE through 30 days after last dose of study drug, Tumor response at the end of every 2nd 28 day cycle, PK/PD assessments on Day 1, 2, 3 (or 4 or 5), and Day 8 of cycle 1

07

Study locations

4 sites
  • California Cancer Care
    Greenbrae, California 94904, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Sarah Cannon Research Institue
    Nashville, Tennessee 37203, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Buggy JJ, Cao ZA, Bass KE, Verner E, Balasubramanian S, Liu L, Schultz BE, Young PR, Dalrymple SA. CRA-024781: a novel synthetic inhibitor of histone deacetylase enzymes with antitumor activity in vitro and in vivo. Mol Cancer Ther. 2006 May;5(5):1309-17. doi: 10.1158/1535-7163.MCT-05-0442. PubMed 16731764 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00562224
Lead sponsor
Pharmacyclics LLC.
Responsible party
Sponsor
First posted
Nov 21, 2007
Start date
Nov 2007
Primary completion
Jun 2010
Completion
Sep 2010
Last update
Sep 28, 2011

Study contacts

Samir Undevia, MD
principal investigator · University of Chicago

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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