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Phase I Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PCI-24781 Administered Orally in Patients With Advanced Cancer

Phase 1
18 Years
Not Enrolling
Neoplasms by Site, Lymphoma, Non-hodgkin, Hodgkin Disease, Multiple Myeloma, Leukemia, Lymphocytic, Chronic

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Trial Information

Phase I Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PCI-24781 Administered Orally in Patients With Advanced Cancer

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

- 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:

- 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

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

at the end of the first 28 day cycle

Safety Issue:


Principal Investigator

Samir Undevia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

September 2010

Related Keywords:

  • Neoplasms by Site
  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
  • Multiple Myeloma
  • Leukemia, Lymphocytic, Chronic
  • PCI-24781
  • Neoplasms by site
  • Lymphoma, non-hodgkin
  • Hodgkin disease
  • Multiple myeloma
  • Leukemia, lymphocytic, chronic
  • Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasms by Site



MD Anderson Cancer Center Houston, Texas  77030-4096
University of Chicago Chicago, Illinois  60637
California Cancer Care Greenbrae, California  94904
Sarah Cannon Research Institue Nashville, Tennessee  37203