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

Phase 1

Completed

• Conditions: Neoplasms by Site; Lymphoma, Non-hodgkin; Hodgkin Disease; Multiple Myeloma; Leukemia, Lymphocytic, Chronic
• Interventions: Drug: PCI-24781

• Registration Number: NCT00562224
• Lead Sponsor: Pharmacyclics LLC.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-21
• Primary Completion: 2010-06
• Study Completion: 2010-09
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-26
• Last Update Posted: 2011-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	PCI-24781	All study subjects will receive PCI-24781 (study drug).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

California Cancer Care; 🇺🇸 Greenbrae, California, United States

Sarah Cannon Research Institue; 🇺🇸 Nashville, Tennessee, United States