NCT01105247 · CITED IN SOURCE DOCUMENTS

Safety of PCI-32765 in Chronic Lymphocytic Leukemia

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2014-03-31

The purpose of this study is to establish the safety and efficacy of orally administered PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events (AEs)

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outcome · POSTED

Food Effect Cohort Assessments

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outcome · POSTED

Progression Free Survival Rate at 24 Months

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outcome · POSTED

Percentage of Participants Achieving Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. FOR TREATMENT-NAIVE GROUP ONLY: Men and women ≥ 65 years of age with confirmed diagnosis of CLL/SLL, who require treatment per NCI or International Working Group guidelines 15-18 2. FOR RELAPSED/REFRACTORY GROUP ONLY: Men and women ≥ 18 years of age with a confirmed diagnosis of relapsed/refractory CLL/SLL following previous therapy(ie, failed ≥ 2 previous treatments for CLL/SLL and at least 1 regimen had to have had a purine analog \[eg, fludarabine\] for subjects with CLL) 3. FOR HIGH-RISK RELAPSED/ REFRACTORYGROUP ONLY: Men and women ≥ 18 years of age with a confirmed diagnosis of relapsed/refractory CLL/SLL with suboptimal response to chemoimmunotherapy, defined as progression of disease within 24 months of initiation of a regimen containing at least a nucleoside analogue or bendamustine in combination with a monoclonal antibody or failure to respond to such a regimen. (Note: a minimum of 2 cycles of chemoimmunotherapy required for eligibility) 4. ECOG performance status of ≤ 2 5. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty Exclusion Criteria: 1. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 2 years or which will not limit survival to \< 2 years 2. Any immunotherapy, chemotherapy, radiotherapy, or experimental therapy within 4 weeks before first dose of study drug (corticosteroids for disease-related symptoms allowed but require 1-week washout before study drug administration) 3. Central nervous system (CNS) involvement by lymphoma 4. Major surgery within 4 weeks before first dose of study drug 5. Concomitant use of medicines known to cause QT prolongation or torsades de pointes 6. Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, bradycardia, and QTc \> 470 msec 7. Lactating or pregnant
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: PCI-32765
label
PCI-32765
type
EXPERIMENTAL

interventions

arm Group Labels
PCI-32765
description
420 mg daily or 840 mg daily
name
PCI-32765
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 133
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Number of participants who had experienced at least one treatment emergent AEs.
measure
Number of Participants With Treatment Emergent Adverse Events (AEs)
time Frame
From first dose to within 30 days of last dose of PCI-32765

secondary Outcomes

description
Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose.
measure
Food Effect Cohort Assessments
time Frame
Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.
description
Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.
measure
Progression Free Survival Rate at 24 Months
time Frame
The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).
description
Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size.
measure
Percentage of Participants Achieving Response
time Frame
The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).

Full study description

brief Summary: The purpose of this study is to establish the safety and efficacy of orally administered PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.

Source references

references

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