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

Pharmacyclics

Status and phase

Completed

Phase 1

Conditions

Lymphoma, Non-hodgkin

Multiple Myeloma

Neoplasms by Site

Hodgkin Disease

Leukemia, Lymphocytic, Chronic

Treatments

Drug: PCI-24781

Study type

Interventional

Funder types

Industry

Identifiers

NCT00562224

PCYC-0402

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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)