Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)
Sponsor
Pharmacyclics LLC. (Industry)
Overall Status
Completed
CT.gov ID
NCT01292135
Collaborator
(none)
33
6
2
26.9
5.5
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
This is a Phase 1b, open-label, parallel-group, nonrandomized, multicenter study of PCI 32765 420 mg once daily oral (PO) administration in combination with 2 different chemotherapy regimens in subjects with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Study Design
Study Type:
Interventional
Actual Enrollment
:
33 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b, Multicenter, Open-label, Parallel-group Safety Study of a Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI 32765, in Combination With Chemotherapy in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study Start Date
:
Feb 1, 2011
Actual Primary Completion Date
:
Nov 1, 2012
Actual Study Completion Date
:
May 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PCI-32765 plus fludarabine/cyclophosphamide/rituximab (FCR)
|
Drug: PCI-32765
420 mg daily
|
| Experimental: PCI-32765 plus bendamustine/rituximab (BR)
|
Drug: PCI-32765
420 mg daily
|
Outcome Measures
Primary Outcome Measures
- Incidence of Prolonged Hematologic Toxicity Started in Cycle 1 [From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.]
Secondary Outcome Measures
- Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib [From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.]
- Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0 [From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.]
- Overall Incidence of Serious Adverse Events (SAEs) [From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.]
- Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR]) [From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 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. Assessment of response to treatment will be done every 2 cycles for the first 6 months and then every 3 months thereafter until disease progression or prior to the administration of a new anticancer therapy and at follow-up visits.
- Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline [From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.]
- Progression Free Survival Rate at 12 Months [From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Histologically confirmed CLL or SLL and satisfying at least 1 of the following criteria for requiring treatment:
-
Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
-
Anemia (<11 g/dL) or thrombocytopenia (<100,000/μL) due to bone marrow involvement
-
Presence of unintentional weight loss > 10% over the preceding 6 months
-
NCI CTCAE Grade 2 or 3 fatigue
-
Fevers > 100.5° or night sweats for > 2 weeks without evidence of infection
-
Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of < 6 months
-
1 to 3 prior treatment regimens for CLL/SLL
-
ECOG performance status of ≤ 1
-
≥ 18 years of age
-
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
-
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Exclusion Criteria:
-
Any chemotherapy, therapeutic antineoplastic antibodies (not including radio- or toxin immunoconjugates), radiation therapy, or experimental antineoplastic therapy within 4 weeks of first dose of study drug
-
Radio- or toxin-conjugated antibody therapy within 10 weeks of first dose of study drug
-
Concomitant use of medicines known to cause QT prolongation or torsades de pointes
-
Transformed lymphoma or Richter's transformation Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
-
Any of the following laboratory abnormalities: oAbsolute neutrophil count (ANC) < 1000 cells/mm3 (1.0 x 109/L) oPlatelet count < 50,000/mm3 (50 x 109/L) oSerum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) oCreatinine > 2.0 x ULN or creatinine clearance < 40 mL/min
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dana Farber Cancer Center | Boston | Massachusetts | United States | 02115 |
| 2 | CLL Research and Treatment Program | New Hyde Park | New York | United States | 11042 |
| 3 | Weill Medical College of Cornell University | New York | New York | United States | 10065 |
| 4 | University of Rochester | Rochester | New York | United States | 14642 |
| 5 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
| 6 | MD Anderson | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Pharmacyclics LLC.
Investigators
- Study Director: Thorsten Graef, MD, Pharmacyclics LLC.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01292135
Other Study ID Numbers:
- PCYC-1108-CA
- PCI-32765
First Posted:
Feb 9, 2011
Last Update Posted:
Jul 24, 2014
Last Verified:
Jul 1, 2014
Keywords provided by Pharmacyclics LLC.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR) | PCI-32765 Plus Bendamustine/Rituximab (BR) |
|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily FCR: Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1(Cycle 2 to Cycle 6). Fludarabine: 25 mg/m2/day for 3 days (Days 1 to 3) of each cycle Cyclophosphamide: 250 mg/m2/day for 3 days (Days 1 to 3) of each cycle (Up to 6 Cycle) | PCI-32765: 420 mg daily BR: Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1 (Cycle 2 to Cycle 6). Bendamustine; 70 mg/m² on Day 1 and 2 of each cycle (Up to 6 Cycles) |
| Period Title: Overall Study | ||
| STARTED | 3 | 30 |
| COMPLETED | 3 | 21 |
| NOT COMPLETED | 0 | 9 |
Baseline Characteristics
| Arm/Group Title | PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR) | PCI-32765 Plus Bendamustine/Rituximab (BR) | Total |
|---|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily | PCI-32765: 420 mg daily | Total of all reporting groups |
| Overall Participants | 3 | 30 | 33 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
56.3
(1.53)
|
61.3
(9.58)
|
60.8
(9.24)
|
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
3
100%
|
19
63.3%
|
22
66.7%
|
| >=65 years |
0
0%
|
11
36.7%
|
11
33.3%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
5
16.7%
|
5
15.2%
|
| Male |
3
100%
|
25
83.3%
|
28
84.8%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
3
100%
|
30
100%
|
33
100%
|
Outcome Measures
| Title | Incidence of Prolonged Hematologic Toxicity Started in Cycle 1 |
|---|---|
| Description | |
| Time Frame | From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FCR arm was discontinued due to very limited use of this chemo regimen in this setting, statistical analysis were limited due to the small numbers of subjects in this treatment arm. |
| Arm/Group Title | PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR) |
|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily | PCI-32765: 420 mg daily |
| Measure Participants | 30 | 3 |
| Number (95% Confidence Interval) [Percentage of Participants] |
0
0%
|
0
0%
|
| Title | Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib |
|---|---|
| Description | |
| Time Frame | From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR) |
|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily | PCI- 32765: 420 mg daily |
| Measure Participants | 30 | 3 |
| Number [Percentage of Participants] |
53.3
1776.7%
|
33.3
111%
|
| Title | Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0 |
|---|---|
| Description | |
| Time Frame | From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR) |
|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily | PCI- 32765: 420 mg daily |
| Measure Participants | 30 | 3 |
| Number [Percentage of Participants] |
66.7
2223.3%
|
0
0%
|
| Title | Overall Incidence of Serious Adverse Events (SAEs) |
|---|---|
| Description | |
| Time Frame | From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR) |
|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily | PCI-32765: 420 mg daily |
| Measure Participants | 30 | 3 |
| Number [Percentage of Participants] |
20
666.7%
|
33.3
111%
|
| Title | Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR]) |
|---|---|
| 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. Assessment of response to treatment will be done every 2 cycles for the first 6 months and then every 3 months thereafter until disease progression or prior to the administration of a new anticancer therapy and at follow-up visits. |
| Time Frame | From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR) |
|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily | PCI-32765: 420 mg daily |
| Measure Participants | 30 | 3 |
| Number (95% Confidence Interval) [Percentage of Participants] |
93.3
3110%
|
100
333.3%
|
| Title | Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline |
|---|---|
| Description | |
| Time Frame | From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participants in the FCR group had neutropenia, anemia or thrombocytopenia at baseline. |
| Arm/Group Title | PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR) |
|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily | PCI-32765: 420 mg daily |
| Measure Participants | 30 | 0 |
| Number (95% Confidence Interval) [Percentage of Participants] |
76.2
2540%
|
| Title | Progression Free Survival Rate at 12 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 | From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI- 32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR) |
|---|---|---|
| Arm/Group Description | PCI-32765: 420 mg daily | PCI-32765: 420 mg daily |
| Measure Participants | 30 | 3 |
| Number (95% Confidence Interval) [Percentage of Participants] |
85.9
2863.3%
|
100
333.3%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI-32765 Plus Fludarabine/ Cyclophosphamide/Rituximab (FCR) | ||
| Arm/Group Description | PCI-32765: 420 mg daily | PCI-32765: 420 mg daily | ||
All Cause Mortality |
||||
| PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI-32765 Plus Fludarabine/ Cyclophosphamide/Rituximab (FCR) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI-32765 Plus Fludarabine/ Cyclophosphamide/Rituximab (FCR) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/30 (20%) | 1/3 (33.3%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 2/30 (6.7%) | 0/3 (0%) | ||
| Gastrointestinal disorders | ||||
| Gastritis | 0/30 (0%) | 1/3 (33.3%) | ||
| Infections and infestations | ||||
| Cellulitis | 2/30 (6.7%) | 0/3 (0%) | ||
| Viral Infection | 0/30 (0%) | 1/3 (33.3%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/30 (3.3%) | 0/3 (0%) | ||
| Tumour lysis syndrome | 1/30 (3.3%) | 0/3 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| PCI-32765 Plus Bendamustine/Rituximab (BR) | PCI-32765 Plus Fludarabine/ Cyclophosphamide/Rituximab (FCR) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 30/30 (100%) | 3/3 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Neutropenia | 12/30 (40%) | 1/3 (33.3%) | ||
| Thrombocytopenia | 5/30 (16.7%) | 2/3 (66.7%) | ||
| Anaemia | 2/30 (6.7%) | 2/3 (66.7%) | ||
| Eye disorders | ||||
| Conjuctivitis | 2/30 (6.7%) | 0/3 (0%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 21/30 (70%) | 1/3 (33.3%) | ||
| Nausea | 20/30 (66.7%) | 2/3 (66.7%) | ||
| Constipation | 9/30 (30%) | 0/3 (0%) | ||
| Vomiting | 9/30 (30%) | 0/3 (0%) | ||
| Gastrooesophageal reflux disease | 6/30 (20%) | 0/3 (0%) | ||
| Abdominal discomfort | 4/30 (13.3%) | 0/3 (0%) | ||
| Dry mouth | 4/30 (13.3%) | 1/3 (33.3%) | ||
| Stomatitis | 4/30 (13.3%) | 1/3 (33.3%) | ||
| Abdominal distension | 3/30 (10%) | 0/3 (0%) | ||
| Dyspepsia | 3/30 (10%) | 1/3 (33.3%) | ||
| Flatulence | 2/30 (6.7%) | 0/3 (0%) | ||
| Mouth ulceration | 2/30 (6.7%) | 0/3 (0%) | ||
| Tongue ulcerlation | 2/30 (6.7%) | 0/3 (0%) | ||
| General disorders | ||||
| Fatigue | 14/30 (46.7%) | 0/3 (0%) | ||
| Oedema peripheral | 10/30 (33.3%) | 0/3 (0%) | ||
| Pyrexia | 7/30 (23.3%) | 0/3 (0%) | ||
| Chills | 5/30 (16.7%) | 0/3 (0%) | ||
| Asthenia | 3/30 (10%) | 0/3 (0%) | ||
| Pain | 3/30 (10%) | 0/3 (0%) | ||
| Chest discomfort | 2/30 (6.7%) | 0/3 (0%) | ||
| Impaired healing | 2/30 (6.7%) | 1/3 (33.3%) | ||
| Immune system disorders | ||||
| Drug hypersensitivity | 2/30 (6.7%) | 0/3 (0%) | ||
| Seasonal allergy | 3/30 (10%) | 0/3 (0%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 11/30 (36.7%) | 1/3 (33.3%) | ||
| Sinusitis | 8/30 (26.7%) | 0/3 (0%) | ||
| Urinary tract infection | 4/30 (13.3%) | 0/3 (0%) | ||
| Cellulitis | 2/30 (6.7%) | 0/3 (0%) | ||
| Nasopharyngitis | 2/30 (6.7%) | 0/3 (0%) | ||
| Pneomonia | 2/30 (6.7%) | 1/3 (33.3%) | ||
| Oral herpes | 0/30 (0%) | 1/3 (33.3%) | ||
| Rhinitis | 1/30 (3.3%) | 1/3 (33.3%) | ||
| Skin Infection | 0/30 (0%) | 1/3 (33.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 6/30 (20%) | 0/3 (0%) | ||
| Arthropod bite | 3/30 (10%) | 0/3 (0%) | ||
| Joint dislocation | 0/30 (0%) | 1/3 (33.3%) | ||
| Investigations | ||||
| Weight decreased | 3/30 (10%) | 0/3 (0%) | ||
| Blood uric acid increased | 2/30 (6.7%) | 0/3 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 5/30 (16.7%) | 0/3 (0%) | ||
| Hyperuricaemia | 4/30 (13.3%) | 1/3 (33.3%) | ||
| Hypomagnesaemia | 4/30 (13.3%) | 2/3 (66.7%) | ||
| Hyperglycaemia | 3/30 (10%) | 1/3 (33.3%) | ||
| Hypocalcaemia | 3/30 (10%) | 3/3 (100%) | ||
| Fluid retention | 2/30 (6.7%) | 0/3 (0%) | ||
| Hypophosphataemia | 2/30 (6.7%) | 1/3 (33.3%) | ||
| Hyponatraemia | 1/30 (3.3%) | 1/3 (33.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 8/30 (26.7%) | 0/3 (0%) | ||
| Muscle spasms | 7/30 (23.3%) | 0/3 (0%) | ||
| Back Pain | 5/30 (16.7%) | 0/3 (0%) | ||
| Myalgia | 5/30 (16.7%) | 1/3 (33.3%) | ||
| Bone pain | 3/30 (10%) | 0/3 (0%) | ||
| Pain in extremity | 3/30 (10%) | 0/3 (0%) | ||
| Muscular weakness | 2/30 (6.7%) | 0/3 (0%) | ||
| Musculoskeletal pain | 0/30 (0%) | 1/3 (33.3%) | ||
| Neck Pain | 0/30 (0%) | 1/3 (33.3%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Squamous cell carcinoma | 6/30 (20%) | 0/3 (0%) | ||
| Basal cell carcinoma | 2/30 (6.7%) | 0/3 (0%) | ||
| Nervous system disorders | ||||
| Headache | 9/30 (30%) | 0/3 (0%) | ||
| Dizziness | 7/30 (23.3%) | 0/3 (0%) | ||
| Paraesthesia | 2/30 (6.7%) | 0/3 (0%) | ||
| Syncope | 2/30 (6.7%) | 0/3 (0%) | ||
| Psychiatric disorders | ||||
| Insomnia | 7/30 (23.3%) | 0/3 (0%) | ||
| Depression | 2/30 (6.7%) | 0/3 (0%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 3/30 (10%) | 0/3 (0%) | ||
| Pollakiuria | 3/30 (10%) | 0/3 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 4/30 (13.3%) | 0/3 (0%) | ||
| Oropharyngeal pain | 4/30 (13.3%) | 0/3 (0%) | ||
| Sinus congestion | 3/30 (10%) | 0/3 (0%) | ||
| Epistaxis | 2/30 (6.7%) | 0/3 (0%) | ||
| Nasal congestion | 2/30 (6.7%) | 0/3 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash maculo papular | 5/30 (16.7%) | 0/3 (0%) | ||
| Increased tendency to bruise | 4/30 (13.3%) | 0/3 (0%) | ||
| Rash | 3/30 (10%) | 0/3 (0%) | ||
| Dermatitis | 2/30 (6.7%) | 0/3 (0%) | ||
| Ecchymosis | 2/30 (6.7%) | 0/3 (0%) | ||
| Onychoclasis | 2/30 (6.7%) | 0/3 (0%) | ||
| Pruritus | 2/30 (6.7%) | 0/3 (0%) | ||
| Sunburn | 2/30 (6.7%) | 0/3 (0%) | ||
| Vascular disorders | ||||
| Flushing | 2/30 (6.7%) | 0/3 (0%) | ||
| Hypotension | 2/30 (6.7%) | 0/3 (0%) | ||
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 | Thorsten Graef, MD |
|---|---|
| Organization | Pharmacyclics |
| Phone | 855.427.8846 |
| medinfo@pcyc.com |
Responsible Party:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01292135
Other Study ID Numbers:
- PCYC-1108-CA
- PCI-32765
First Posted:
Feb 9, 2011
Last Update Posted:
Jul 24, 2014
Last Verified:
Jul 1, 2014