Safety of PCI-32765 in Chronic Lymphocytic Leukemia
Sponsor
Pharmacyclics LLC. (Industry)
Overall Status
Completed
CT.gov ID
NCT01105247
Collaborator
(none)
133
10
1
33.1
13.3
0.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
133 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b/2 Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia
Study Start Date
:
May 1, 2010
Actual Primary Completion Date
:
Dec 1, 2012
Actual Study Completion Date
:
Feb 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PCI-32765
|
Drug: PCI-32765
420 mg daily or 840 mg daily
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events (AEs) [From first dose to within 30 days of last dose of PCI-32765]
Number of participants who had experienced at least one treatment emergent AEs.
Secondary Outcome Measures
- Food Effect Cohort Assessments [Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.]
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.
- Progression Free Survival Rate at 24 Months [The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).]
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.
- Percentage of Participants Achieving Response [The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
-
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)
-
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)
-
ECOG performance status of ≤ 2
-
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
Exclusion Criteria:
-
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
-
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)
-
Central nervous system (CNS) involvement by lymphoma
-
Major surgery within 4 weeks before first dose of study drug
-
Concomitant use of medicines known to cause QT prolongation or torsades de pointes
-
Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, bradycardia, and QTc > 470 msec
-
Lactating or pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
| 2 | New York Presbyterian Hosptial Cornell Med Center | New York | New York | United States | 10065 |
| 3 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 4 | Willamette Valley Cancer Institute and Research Center | Springfield | Oregon | United States | 97477 |
| 5 | Sarah Cannon | Nashville | Tennessee | United States | 37203 |
| 6 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 7 | Texas Oncology - Tyler | Tyler | Texas | United States | 75702 |
| 8 | University of Vermont and Fletcher Allen Health Care | Burlington | Vermont | United States | 05405 |
| 9 | Northwest Cancer Specialists, P.C. | Vancouver | Washington | United States | 98686 |
| 10 | Yakima Valley Memorial | Yakima | Washington | United States | 98902 |
Sponsors and Collaborators
- Pharmacyclics LLC.
Investigators
- Study Director: Danelle James, M.D., M.A.S, Pharmacyclics LLC.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01105247
Other Study ID Numbers:
- PCYC-1102-CA
- PCI-32765
First Posted:
Apr 16, 2010
Last Update Posted:
Mar 31, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Pharmacyclics LLC.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | There are total 133 subjects enrolled however one subject never received treatment. Therefore, number of subjects "Started" the study is listed as 132 subjects. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PCI-32765 | Food Effect Cohort |
|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily or 840 mg daily. | PCI-32765: 420 mg daily |
| Period Title: Overall Study | ||
| STARTED | 116 | 16 |
| COMPLETED | 79 | 16 |
| NOT COMPLETED | 37 | 0 |
Baseline Characteristics
| Arm/Group Title | PCI-32765 | Food Effect Cohort | Total |
|---|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily or 840 mg daily | PCI-32765: 420 mg daily | Total of all reporting groups |
| Overall Participants | 116 | 16 | 132 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
42
36.2%
|
9
56.3%
|
51
38.6%
|
| >=65 years |
74
63.8%
|
7
43.8%
|
81
61.4%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
32
27.6%
|
2
12.5%
|
34
25.8%
|
| Male |
84
72.4%
|
14
87.5%
|
98
74.2%
|
Outcome Measures
| Title | Number of Participants With Treatment Emergent Adverse Events (AEs) |
|---|---|
| Description | Number of participants who had experienced at least one treatment emergent AEs. |
| Time Frame | From first dose to within 30 days of last dose of PCI-32765 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | PCI-32765 | Food Effect |
|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily or 840 mg daily | Food-Effect Relapsed/Refractory participants received PCI-32765 420 mg daily |
| Measure Participants | 116 | 16 |
| Number [Participants] |
116
100%
|
11
68.8%
|
| Title | Food Effect Cohort Assessments |
|---|---|
| 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. |
| Time Frame | Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Note: 16 subjects were participated in food effect cohort. However, the PK parameters for 1 subject under Fasted treatment period cannot be reliably estimated. The data for this subject were excluded from Fed/Fasted comparison. |
| Arm/Group Title | Food Effect Cohort |
|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily |
| Measure Participants | 15 |
| Number (90% Confidence Interval) |
1.65
|
| Title | Progression Free Survival Rate at 24 Months |
|---|---|
| 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. |
| Time Frame | The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/ Refractory | Food- Effect |
|---|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily or 840 mg daily | PCI-32765: 420 mg daily or 840 mg daily | Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily |
| Measure Participants | 31 | 85 | 16 |
| Number (95% Confidence Interval) [Percentage of Participants] |
96.3
83%
|
73.6
460%
|
NA
NaN
|
| Title | Percentage of Participants Achieving Response |
|---|---|
| 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. |
| Time Frame | The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/ Refractory | Food Effect |
|---|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily or 840 mg daily | PCI-32765: 420 mg daily or 840 mg daily | Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily |
| Measure Participants | 31 | 85 | 16 |
| Number (95% Confidence Interval) [Percentage of Participants] |
71
61.2%
|
75.3
470.6%
|
56.3
42.7%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | PCI-32765 | Food Effect | ||
| Arm/Group Description | PCI-32765: 420 mg daily or 840 mg daily | PCI-32765: 420 mg daily | ||
All Cause Mortality |
||||
| PCI-32765 | Food Effect | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| PCI-32765 | Food Effect | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 61/116 (52.6%) | 7/16 (43.8%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 5/116 (4.3%) | 0/16 (0%) | ||
| Splenomegaly | 2/116 (1.7%) | 0/16 (0%) | ||
| Idiopathic thrombocytopenic purpura | 1/116 (0.9%) | 0/16 (0%) | ||
| Lymphocytosis | 1/116 (0.9%) | 0/16 (0%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 4/116 (3.4%) | 0/16 (0%) | ||
| Angina pectoris | 1/116 (0.9%) | 0/16 (0%) | ||
| Supraventricular tachycardia | 1/116 (0.9%) | 0/16 (0%) | ||
| Eye disorders | ||||
| Vision blurred | 1/116 (0.9%) | 0/16 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 2/116 (1.7%) | 0/16 (0%) | ||
| Diarrhoea | 2/116 (1.7%) | 0/16 (0%) | ||
| Abdominal adhesions | 1/116 (0.9%) | 0/16 (0%) | ||
| Enterocolitis haemorrhagic | 1/116 (0.9%) | 0/16 (0%) | ||
| Gastrointestinal haemorrhage | 1/116 (0.9%) | 0/16 (0%) | ||
| Ileus | 1/116 (0.9%) | 0/16 (0%) | ||
| Nausea | 1/116 (0.9%) | 0/16 (0%) | ||
| Vomiting | 1/116 (0.9%) | 0/16 (0%) | ||
| General disorders | ||||
| Asthenia | 1/116 (0.9%) | 0/16 (0%) | ||
| Pyrexia | 1/116 (0.9%) | 0/16 (0%) | ||
| Systemic inflammatory response syndrome | 1/116 (0.9%) | 0/16 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 11/116 (9.5%) | 4/16 (25%) | ||
| Bacteraemia | 4/116 (3.4%) | 0/16 (0%) | ||
| Cellulitis | 4/116 (3.4%) | 0/16 (0%) | ||
| Sinusitis | 4/116 (3.4%) | 0/16 (0%) | ||
| Sepsis | 3/116 (2.6%) | 0/16 (0%) | ||
| Clostridial infection | 2/116 (1.7%) | 0/16 (0%) | ||
| Pneumonia viral | 2/116 (1.7%) | 0/16 (0%) | ||
| Bacterial sepsis | 1/116 (0.9%) | 0/16 (0%) | ||
| Bronchitis viral | 1/116 (0.9%) | 1/16 (6.3%) | ||
| Chronic sinusitis | 1/116 (0.9%) | 0/16 (0%) | ||
| Citrobacter infection | 1/116 (0.9%) | 0/16 (0%) | ||
| Clostridium difficile colitis | 1/116 (0.9%) | 0/16 (0%) | ||
| Cystitis | 1/116 (0.9%) | 0/16 (0%) | ||
| Device related infection | 1/116 (0.9%) | 0/16 (0%) | ||
| Gastroenteritis | 1/116 (0.9%) | 0/16 (0%) | ||
| Herpes zoster disseminated | 1/116 (0.9%) | 0/16 (0%) | ||
| Joint abscess | 1/116 (0.9%) | 0/16 (0%) | ||
| Labyrinthitis | 1/116 (0.9%) | 0/16 (0%) | ||
| Lobar pneumonia | 1/116 (0.9%) | 0/16 (0%) | ||
| Mycobacterium avium complex infection | 1/116 (0.9%) | 0/16 (0%) | ||
| Pneumonia cryptococcal | 1/116 (0.9%) | 0/16 (0%) | ||
| Pneumonia influenzal | 1/116 (0.9%) | 0/16 (0%) | ||
| Pneumonia streptococcal | 1/116 (0.9%) | 0/16 (0%) | ||
| Rhinovirus infection | 1/116 (0.9%) | 0/16 (0%) | ||
| Staphylococcal bacteraemia | 1/116 (0.9%) | 1/16 (6.3%) | ||
| Upper respiratory tract infection | 1/116 (0.9%) | 0/16 (0%) | ||
| Urinary tract infection | 1/116 (0.9%) | 0/16 (0%) | ||
| Varicella | 1/116 (0.9%) | 0/16 (0%) | ||
| Vestibular neuronitis | 1/116 (0.9%) | 0/16 (0%) | ||
| Viral Infection | 1/116 (0.9%) | 0/16 (0%) | ||
| Viral upper respiratory tract infection | 1/116 (0.9%) | 0/16 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Subdural haematoma | 2/116 (1.7%) | 0/16 (0%) | ||
| Laceration | 1/116 (0.9%) | 0/16 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Hypercalcaemia | 2/116 (1.7%) | 0/16 (0%) | ||
| Decreased appetite | 1/116 (0.9%) | 0/16 (0%) | ||
| Dehydration | 1/116 (0.9%) | 0/16 (0%) | ||
| Hyperglycaemia | 1/116 (0.9%) | 0/16 (0%) | ||
| Hyponatraemia | 1/116 (0.9%) | 0/16 (0%) | ||
| Tumour lysis syndrome | 1/116 (0.9%) | 0/16 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 2/116 (1.7%) | 0/16 (0%) | ||
| Bone lesion | 1/116 (0.9%) | 0/16 (0%) | ||
| Bursitis | 1/116 (0.9%) | 0/16 (0%) | ||
| Cervical spinal stenosis | 1/116 (0.9%) | 0/16 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Richter's syndrome | 2/116 (1.7%) | 0/16 (0%) | ||
| Chronic lymphocytic leukaemia | 1/116 (0.9%) | 0/16 (0%) | ||
| Leukostasis | 1/116 (0.9%) | 0/16 (0%) | ||
| Malignant histiocytosis | 1/116 (0.9%) | 0/16 (0%) | ||
| Peripheral T-cell lymphoma unspecified | 1/116 (0.9%) | 0/16 (0%) | ||
| Prostate cancer | 1/116 (0.9%) | 0/16 (0%) | ||
| Squamous cell carcinoma | 1/116 (0.9%) | 0/16 (0%) | ||
| Nervous system disorders | ||||
| Dizziness | 2/116 (1.7%) | 0/16 (0%) | ||
| Cerebrovascular accident | 1/116 (0.9%) | 0/16 (0%) | ||
| Headache | 1/116 (0.9%) | 0/16 (0%) | ||
| Hypertensive encephalopathy | 1/116 (0.9%) | 0/16 (0%) | ||
| Transient ischaemic attack | 1/116 (0.9%) | 0/16 (0%) | ||
| Syncope | 0/116 (0%) | 1/16 (6.3%) | ||
| Renal and urinary disorders | ||||
| Cystitis noninfective | 1/116 (0.9%) | 0/16 (0%) | ||
| Urinary retention | 1/116 (0.9%) | 0/16 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Hypoxia | 1/116 (0.9%) | 0/16 (0%) | ||
| Pleuritic pain | 1/116 (0.9%) | 0/16 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash maculo-papular | 1/116 (0.9%) | 0/16 (0%) | ||
| Vascular disorders | ||||
| Hypertension | 1/116 (0.9%) | 0/16 (0%) | ||
| Orthostatic hypotension | 1/116 (0.9%) | 0/16 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| PCI-32765 | Food Effect | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 116/116 (100%) | 16/16 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 19/116 (16.4%) | 0/16 (0%) | ||
| Neutropenia | 16/116 (13.8%) | 2/16 (12.5%) | ||
| Thrombocytopenia | 15/116 (12.9%) | 0/16 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Hydrocele | 0/116 (0%) | 1/16 (6.3%) | ||
| Eye disorders | ||||
| Dry eye | 11/116 (9.5%) | 0/16 (0%) | ||
| Cataract | 6/116 (5.2%) | 0/16 (0%) | ||
| Conjunctivitis | 6/116 (5.2%) | 1/16 (6.3%) | ||
| Vision Blurred | 6/116 (5.2%) | 1/16 (6.3%) | ||
| Conjuctival hyperaemia | 0/116 (0%) | 1/16 (6.3%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 25/116 (21.6%) | 1/16 (6.3%) | ||
| Dyspepsia | 17/116 (14.7%) | 0/16 (0%) | ||
| Stomatitis | 16/116 (13.8%) | 1/16 (6.3%) | ||
| Gastrooesophageal reflux disease | 13/116 (11.2%) | 1/16 (6.3%) | ||
| Dry mouth | 7/116 (6%) | 0/16 (0%) | ||
| Aphthous stomatitis | 6/116 (5.2%) | 0/16 (0%) | ||
| Diarrhoea | 65/116 (56%) | 11/16 (68.8%) | ||
| Vomiting | 22/116 (19%) | 11/16 (68.8%) | ||
| Food poisoning | 0/116 (0%) | 2/16 (12.5%) | ||
| Nausea | 31/116 (26.7%) | 2/16 (12.5%) | ||
| Abdominal distension | 5/116 (4.3%) | 1/16 (6.3%) | ||
| Haemorrhoids | 3/116 (2.6%) | 1/16 (6.3%) | ||
| Inguinal hernia | 0/116 (0%) | 1/16 (6.3%) | ||
| Mouth haemorrhage | 0/116 (0%) | 1/16 (6.3%) | ||
| Oral mucosal blistering | 1/116 (0.9%) | 1/16 (6.3%) | ||
| General disorders | ||||
| Fatigue | 38/116 (32.8%) | 4/16 (25%) | ||
| Oedema peripheral | 33/116 (28.4%) | 1/16 (6.3%) | ||
| Chills | 14/116 (12.1%) | 3/16 (18.8%) | ||
| Malaise | 9/116 (7.8%) | 1/16 (6.3%) | ||
| Pain | 6/116 (5.2%) | 1/16 (6.3%) | ||
| Early satiety | 3/116 (2.6%) | 1/16 (6.3%) | ||
| Injection site haematoma | 0/116 (0%) | 1/16 (6.3%) | ||
| Hypogammaglobulinaemia | 4/116 (3.4%) | 1/16 (6.3%) | ||
| Immune system disorders | ||||
| Allergy to arthropod bite | 7/116 (6%) | 0/16 (0%) | ||
| Infections and infestations | ||||
| Bronchitis | 9/116 (7.8%) | 0/16 (0%) | ||
| Nasopharyngitis | 8/116 (6.9%) | 0/16 (0%) | ||
| Fungal infection | 6/116 (5.2%) | 1/16 (6.3%) | ||
| Gastroenteritis viral | 6/116 (5.2%) | 0/16 (0%) | ||
| Oral herpes | 6/116 (5.2%) | 0/16 (0%) | ||
| Upper respiratory tract infection | 37/116 (31.9%) | 4/16 (25%) | ||
| Cellulitis | 7/116 (6%) | 1/16 (6.3%) | ||
| Folliculitis | 5/116 (4.3%) | 1/16 (6.3%) | ||
| Furuncle | 0/116 (0%) | 1/16 (6.3%) | ||
| Skin infection | 3/116 (2.6%) | 1/16 (6.3%) | ||
| Urinary track infection | 14/116 (12.1%) | 1/16 (6.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 22/116 (19%) | 4/16 (25%) | ||
| Arthropod bite | 8/116 (6.9%) | 2/16 (12.5%) | ||
| Laceration | 7/116 (6%) | 2/16 (12.5%) | ||
| Excoriation | 2/116 (1.7%) | 1/16 (6.3%) | ||
| Facial bones fracture | 0/116 (0%) | 1/16 (6.3%) | ||
| Lip injury | 0/116 (0%) | 1/16 (6.3%) | ||
| Scratch | 1/116 (0.9%) | 1/16 (6.3%) | ||
| Investigations | ||||
| Weight decreased | 8/116 (6.9%) | 0/16 (0%) | ||
| Blood urea increased | 2/116 (1.7%) | 1/16 (6.3%) | ||
| Cardiac murmur | 4/116 (3.4%) | 1/16 (6.3%) | ||
| Metabolism and nutrition disorders | ||||
| Hypokalaemia | 13/116 (11.2%) | 1/16 (6.3%) | ||
| Hyperuricaemia | 11/116 (9.5%) | 1/16 (6.3%) | ||
| Hypomagnesaemia | 10/116 (8.6%) | 1/16 (6.3%) | ||
| Hyperkalaemia | 8/116 (6.9%) | 0/16 (0%) | ||
| Hyperglycaemia | 5/116 (4.3%) | 2/16 (12.5%) | ||
| Decreased appetite | 0/116 (0%) | 1/16 (6.3%) | ||
| Fluid retention | 4/116 (3.4%) | 1/16 (6.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 31/116 (26.7%) | 5/16 (31.3%) | ||
| Muscle spasms | 21/116 (18.1%) | 3/16 (18.8%) | ||
| Myalgia | 15/116 (12.9%) | 0/16 (0%) | ||
| Pain in extremity | 13/116 (11.2%) | 0/16 (0%) | ||
| Musculoskeletal pain | 8/116 (6.9%) | 0/16 (0%) | ||
| Joint swelling | 6/116 (5.2%) | 0/16 (0%) | ||
| Pain in extremity | 13/116 (11.2%) | 3/16 (18.8%) | ||
| Back pain | 10/116 (8.6%) | 1/16 (6.3%) | ||
| Exostosis | 0/116 (0%) | 1/16 (6.3%) | ||
| Muscular weakness | 3/116 (2.6%) | 1/16 (6.3%) | ||
| Pain in jaw | 1/116 (0.9%) | 1/16 (6.3%) | ||
| Plantar fasciitis | 2/116 (1.7%) | 1/16 (6.3%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Basal cell carcinoma | 11/116 (9.5%) | 0/16 (0%) | ||
| Seborrhoeic keratosis | 6/116 (5.2%) | 0/16 (0%) | ||
| Squamous cell carcinoma | 8/116 (6.9%) | 1/16 (6.3%) | ||
| Nervous system disorders | ||||
| Peripheral sensory neuropathy | 10/116 (8.6%) | 0/16 (0%) | ||
| Headache | 22/116 (19%) | 4/16 (25%) | ||
| Psychiatric disorders | ||||
| Anxiety | 15/116 (12.9%) | 1/16 (6.3%) | ||
| Insomnia | 14/116 (12.1%) | 1/16 (6.3%) | ||
| Depression | 4/116 (3.4%) | 1/16 (6.3%) | ||
| Renal and urinary disorders | ||||
| Urinary retention | 3/116 (2.6%) | 2/16 (12.5%) | ||
| Obstructive uropathy | 0/116 (0%) | 1/16 (6.3%) | ||
| Urethral haemorrhage | 0/116 (0%) | 1/16 (6.3%) | ||
| Reproductive system and breast disorders | ||||
| Erectile dysfunction | 0/116 (0%) | 1/16 (6.3%) | ||
| Scrotal oedema | 0/116 (0%) | 1/16 (6.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 27/116 (23.3%) | 2/16 (12.5%) | ||
| Oropharyngeal pain | 16/116 (13.8%) | 1/16 (6.3%) | ||
| Epistaxis | 13/116 (11.2%) | 4/16 (25%) | ||
| Dyspnoea | 10/116 (8.6%) | 1/16 (6.3%) | ||
| Nasal congestion | 10/116 (8.6%) | 0/16 (0%) | ||
| Dyspnoea exertional | 9/116 (7.8%) | 1/16 (6.3%) | ||
| Productive cough | 8/116 (6.9%) | 0/16 (0%) | ||
| Sinus congestion | 7/116 (6%) | 0/16 (0%) | ||
| Lung infiltration | 1/116 (0.9%) | 1/16 (6.3%) | ||
| Nasal mucosal disorder | 0/116 (0%) | 1/16 (6.3%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Petechiae | 17/116 (14.7%) | 0/16 (0%) | ||
| Increased tendency to bruise | 14/116 (12.1%) | 3/16 (18.8%) | ||
| Rash pruritic | 11/116 (9.5%) | 1/16 (6.3%) | ||
| Pruritus | 10/116 (8.6%) | 0/16 (0%) | ||
| Ecchymosis | 8/116 (6.9%) | 0/16 (0%) | ||
| Erythema | 8/116 (6.9%) | 0/16 (0%) | ||
| Rash | 8/116 (6.9%) | 0/16 (0%) | ||
| Rash macular | 7/116 (6%) | 0/16 (0%) | ||
| Dermatitis acneiform | 6/116 (5.2%) | 0/16 (0%) | ||
| Actinic keratosis | 4/116 (3.4%) | 2/16 (12.5%) | ||
| Blood blister | 2/116 (1.7%) | 2/16 (12.5%) | ||
| Rash papular | 1/116 (0.9%) | 2/16 (12.5%) | ||
| Blister | 1/116 (0.9%) | 1/16 (6.3%) | ||
| Pityriasis | 0/116 (0%) | 1/16 (6.3%) | ||
| Pseudoporphyria | 0/116 (0%) | 1/16 (6.3%) | ||
| Skin lesion | 5/116 (4.3%) | 1/16 (6.3%) | ||
| Skin ulcer | 3/116 (2.6%) | 1/16 (6.3%) | ||
| Urticaria | 0/116 (0%) | 1/16 (6.3%) | ||
| Vascular disorders | ||||
| Hypotension | 8/116 (6.9%) | 0/16 (0%) | ||
| Hypertension | 27/116 (23.3%) | 2/16 (12.5%) | ||
| Lymphoedema | 1/116 (0.9%) | 1/16 (6.3%) | ||
| Orthostatic hypotension | 0/116 (0%) | 1/16 (6.3%) | ||
| Venous insufficiency | 0/116 (0%) | 1/16 (6.3%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Danelle James |
|---|---|
| Organization | Pharmacyclics |
| Phone | 855-427-8846 |
| medinfo@pcyc.com |
Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01105247
Other Study ID Numbers:
- PCYC-1102-CA
- PCI-32765
First Posted:
Apr 16, 2010
Last Update Posted:
Mar 31, 2014
Last Verified:
Feb 1, 2014