PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00303953
• Collaborator: (none)
• Enrollment: 22
• Locations: 123
• Arm: 1
• Duration (Months): 55
• Patients Per Site: 0.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma	Drug: belinostat	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. Evaluate response rate in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma treated with PXD101.

SECONDARY OBJECTIVES:

1. Determine the toxicity of this drug in these patients. II. Estimate the 6-month progression-free survival rate in patients treated with this drug.

TERTIARY OBJECTIVES:

1. Determine the major histocompatability complex of class II proteins (HLA-DR, -DP, -DQ), TUNEL, and CD8 infiltration status, by immunochemistry on paired pre- and post-treatment tumor samples, in the first 20 patients enrolled.

2. Measure CIITA and HLA-DR mRNA expression using quantitative reverse transcriptase-polymerase chain reaction and determine, preliminarily, the associations of these markers with progression-free survival.

3. Evaluate paired pre- and post-treatment peripheral blood mononuclear cells from patients for histone acetylation status and determine correlation with findings from duplicate experiments on pre- and post-needle core biopsies.

OUTLINE: This is a multicenter study.

Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Needle core biopsies and peripheral blood mononuclear cells are obtained from the first 20 patients pre- and post-treatment for biomarker correlative studies.

After completion of study treatment, patients are followed every 3-6 months for up to 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients will receive an infusion of PXD101 once a day for 5 days. Treatment may repeat every 3 weeks for up to 2 years. Some patients will also undergo core biopsy and blood collection for laboratory studies before and after treatment. After finishing treatment, patients will be evaluated every 3-6 months for up to 3 years.	Drug: belinostat; Given IV; Other Names: PXD101

Outcome Measures

Primary Outcome Measures

1. Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) [assessed at week 8, and every 3 months for 3 years]

   Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.

Secondary Outcome Measures

1. Overall Survival [assessed every 3 months for 3 years]

   Measured from time of registration to death, or last contact date

2. Progression-free Survival [assessed at week 8, then every 3 months for 3 years]

   Measured from date of registration to time of first documentation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Biopsy-proven (no needle aspirations or cytologies) aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following histology subtypes:

• Diffuse large cell NHL

• Burkitt's or Burkitt-like NHL

• Primary mediastinal NHL

• Relapsed or refractory disease

• Bidimensionally measurable disease

• Transformed NHL allowed

• Not eligible for stem cell transplantation (for patients registered to study at first relapse)

• No active CNS involvement by lymphoma

• Zubrod performance status 0-2

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101

• Absolute neutrophil count >= 1,500/mm^3

• Platelet count>=100,000/mm^3

• WBC >= 3,000/mm^3

• Creatinine < 2 times upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min

• No significant EKG abnormalities

• Bilirubin normal

• SGOT/SGPT < 2.5 times ULN (=< 5 times ULN if liver involvement)

• No long QT syndrome or marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of QTc interval > 500 msec)

• No other significant cardiovascular disease, including any of the following:

• Unstable angina pectoris

• Uncontrolled hypertension

• Congestive heart failure related to primary cardiac disease

• Any condition requiring anti-arrhythmic therapy

• Ischemic or severe valvular heart disease

• Myocardial infarction within the past 6 months

• No major surgery within 28 days prior to study entry

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent medication that may cause Torsades de Pointes (i.e., prolongation of the QT interval > 500 msec)

• At least 14 days since prior radiotherapy

• At least 2 weeks since prior valproic acid or any other histone deacetylase inhibitor

• No clinical evidence of any of the following:

• Severe peripheral vascular disease

• Diabetic ulcers or venous stasis ulcers

• History of deep venous or arterial thrombosis within the past 3 months

• Radioimmunotherapy is considered a chemotherapy regimen

• Single-agent rituximab is not considered a chemotherapy regimen

• Standard salvage chemotherapy followed by autologous stem cell transplantation is considered 1 regimen

• No known AIDS or HIV-associated complex

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix

• At least 2 weeks since prior therapy and recovered

• No more than 5 prior chemotherapy regimens

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Hospital	Mobile	Alabama	United States	36608
2	University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724
3	NEA Baptist Memorial Hospital	Jonesboro	Arkansas	United States	72401
4	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
5	East Bay Radiation Oncology Center	Castro Valley	California	United States	94546
6	Eden Hospital Medical Center	Castro Valley	California	United States	94546
7	Valley Medical Oncology Consultants-Castro Valley	Castro Valley	California	United States	94546
8	Valley Medical Oncology Consultants-Fremont	Fremont	California	United States	94538
9	Marin General Hospital	Greenbrae	California	United States	94904
10	Saint Rose Hospital	Hayward	California	United States	94545
11	Contra Costa Regional Medical Center	Martinez	California	United States	94553-3156
12	Highland General Hospital	Oakland	California	United States	94602
13	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
14	Bay Area Breast Surgeons Inc	Oakland	California	United States	94609
15	Bay Area Tumor Institute CCOP	Oakland	California	United States	94609
16	Larry G Strieff MD Medical Corporation	Oakland	California	United States	94609
17	Tom K Lee Inc	Oakland	California	United States	94609
18	Valley Care Health System - Pleasanton	Pleasanton	California	United States	94588
19	Valley Medical Oncology Consultants	Pleasanton	California	United States	94588
20	Doctors Medical Center- JC Robinson Regional Cancer Center	San Pablo	California	United States	94806
21	Sutter Solano Medical Center	Vallejo	California	United States	94589
22	Cancer Centers of Central Florida PA	Leesburg	Florida	United States	34788
23	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
24	Advocate Sherman Hospital	Elgin	Illinois	United States	60123
25	Loyola University Medical Center	Maywood	Illinois	United States	60153
26	Memorial Medical Center	Springfield	Illinois	United States	62781-0001
27	Saint Francis Hospital and Health Centers	Beech Grove	Indiana	United States	46107
28	Reid Hospital and Health Care Services	Richmond	Indiana	United States	47374
29	Providence Medical Center	Kansas City	Kansas	United States	66112
30	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
31	Menorah Medical Center	Overland Park	Kansas	United States	66209
32	Radiation Oncology Practice Corporation Southwest	Overland Park	Kansas	United States	66210
33	Salina Regional Health Center	Salina	Kansas	United States	67401
34	Shawnee Mission Medical Center	Shawnee Mission	Kansas	United States	66204
35	Baton Rouge General Medical Center	Baton Rouge	Louisiana	United States	70806
36	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana	United States	70809
37	DeSoto Regional Health System	Mansfield	Louisiana	United States	71052
38	Louisiana State University Sciences Center- Monroe	Monroe	Louisiana	United States	71210
39	Interim LSU Public Hospital	New Orleans	Louisiana	United States	70112
40	Louisiana State University Health Science Center	New Orleans	Louisiana	United States	70112
41	Highland Clinic	Shreveport	Louisiana	United States	71105
42	Louisiana State University Health Sciences Center Shreveport	Shreveport	Louisiana	United States	71130
43	Boston Medical Center	Boston	Massachusetts	United States	02118
44	Henry Ford Hospital	Detroit	Michigan	United States	48202
45	Centerpoint Medical Center LLC	Independence	Missouri	United States	64057
46	Truman Medical Center	Kansas City	Missouri	United States	64108
47	Saint Luke's Cancer Institute	Kansas City	Missouri	United States	64111
48	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
49	Radiation Oncology Practice Corporation South	Kansas City	Missouri	United States	64114
50	Saint Joseph Health Center	Kansas City	Missouri	United States	64114
51	North Kansas City Hospital	Kansas City	Missouri	United States	64116
52	Research Medical Center	Kansas City	Missouri	United States	64132
53	Radiation Oncology Practice Corporation - North	Kansas City	Missouri	United States	64154
54	Liberty Hospital	Liberty	Missouri	United States	64068
55	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
56	Montana Cancer Consortium CCOP	Billings	Montana	United States	59101
57	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
58	Saint Vincent Healthcare	Billings	Montana	United States	59101
59	Hematology-Oncology Centers of the Northern Rockies PC	Billings	Montana	United States	59102
60	Billings Clinic	Billings	Montana	United States	59107-7000
61	Deaconess Medical Center	Billings	Montana	United States	59107
62	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
63	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
64	Internal Medicine of Bozeman	Bozeman	Montana	United States	59715
65	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana	United States	59701
66	Berdeaux, Donald MD (UIA Investigator)	Great Falls	Montana	United States	59405
67	Great Falls Clinic	Great Falls	Montana	United States	59405
68	Northern Montana Hospital	Havre	Montana	United States	59501
69	Saint Peter's Community Hospital	Helena	Montana	United States	59601
70	Glacier Oncology PLLC	Kalispell	Montana	United States	59901
71	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
72	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
73	Community Medical Hospital	Missoula	Montana	United States	59801
74	Montana Cancer Specialists	Missoula	Montana	United States	59802
75	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
76	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
77	Highland Hospital	Rochester	New York	United States	14620
78	Wayne Radiation Oncology	Goldsboro	North Carolina	United States	27534
79	Wilson Medical Center	Wilson	North Carolina	United States	27893
80	University of Cincinnati	Cincinnati	Ohio	United States	45267
81	Grandview Hospital	Dayton	Ohio	United States	45405
82	Good Samaritan Hospital - Dayton	Dayton	Ohio	United States	45406
83	Miami Valley Hospital	Dayton	Ohio	United States	45409
84	Samaritan North Health Center	Dayton	Ohio	United States	45415
85	Dayton CCOP	Dayton	Ohio	United States	45420
86	Veteran Affairs Medical Center	Dayton	Ohio	United States	45428
87	Blanchard Valley Hospital	Findlay	Ohio	United States	45840
88	Atrium Medical Center-Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
89	Kettering Medical Center	Kettering	Ohio	United States	45429
90	Upper Valley Medical Center	Troy	Ohio	United States	45373
91	Clinton Memorial Hospital	Wilmington	Ohio	United States	45177
92	Greene Memorial Hospital	Xenia	Ohio	United States	45385
93	McLeod Regional Medical Center	Florence	South Carolina	United States	29506
94	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
95	Wilford Hall Medical Center	Lackland AFB	Texas	United States	78236
96	Southwest Oncology Group	San Antonio	Texas	United States	78245
97	American Fork Hospital	American Fork	Utah	United States	84003
98	Sandra L Maxwell Cancer Center	Cedar City	Utah	United States	84720
99	Logan Regional Hospital	Logan	Utah	United States	84321
100	Cottonwood Hospital Medical Center	Murray	Utah	United States	84107
101	Intermountain Medical Center	Murray	Utah	United States	84157
102	McKay-Dee Hospital Center	Ogden	Utah	United States	84403
103	Utah Valley Regional Medical Center	Provo	Utah	United States	84604-3337
104	Dixie Medical Center Regional Cancer Center	Saint George	Utah	United States	84770
105	Intermountain Health Care	Salt Lake City	Utah	United States	84103
106	Utah Cancer Specialists-Salt Lake City	Salt Lake City	Utah	United States	84106
107	LDS Hospital	Salt Lake City	Utah	United States	84143
108	PeaceHealth Saint Joseph Medical Center	Bellingham	Washington	United States	98225
109	Harrison HealthPartners Hematology and Oncology-Bremerton	Bremerton	Washington	United States	98310
110	Columbia Basin Hematology and Oncology PLLC	Kennewick	Washington	United States	99336
111	Skagit Valley Hospital	Mount Vernon	Washington	United States	98274
112	Harborview Medical Center	Seattle	Washington	United States	98104
113	Minor and James Medical PLLC	Seattle	Washington	United States	98104
114	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington	United States	98109
115	Group Health Cooperative-Seattle	Seattle	Washington	United States	98112
116	Swedish Medical Center-First Hill	Seattle	Washington	United States	98122-4307
117	The Polyclinic	Seattle	Washington	United States	98122
118	University of Washington Medical Center	Seattle	Washington	United States	98195
119	United General Hospital	Sedro-Woolley	Washington	United States	98284
120	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
121	Madigan Army Medical Center	Tacoma	Washington	United States	98431
122	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801
123	Welch Cancer Center	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Steven Bernstein, Southwest Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00303953
• Other Study ID Numbers: NCI-2009-01096; NCI-2009-01096; CDR0000462614; S0520; S0520; U10CA032102
• First Posted: Mar 17, 2006
• Last Update Posted: May 12, 2014
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Burkitt Lymphoma; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Recurrence; Belinostat

Study Results

Participant Flow

Arm/Group Title	PXD101
Arm/Group Description	Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
Period Title: Overall Study
STARTED	22
Eligible	21
Eligible and Treated	20
COMPLETED	3
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	PXD101
Arm/Group Description	Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
Overall Participants	20
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	68.9
Sex: Female, Male (Count of Participants)
Female	9 45%
Male	11 55%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	19 95%
Unknown or Not Reported	1 5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	19 95%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Description	Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Time Frame	assessed at week 8, and every 3 months for 3 years

Outcome Measure Data

Analysis Population Description

All eligible patients who started treatment were included in assessing response estimates.

Arm/Group Title	PXD101
Arm/Group Description	Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
Measure Participants	20
Complete Response (CR)	0 0%
Complete Response Unconfirmed (CRU)	0 0%
Partial Response (PR)	0 0%
No response	20 100%

2. Secondary Outcome

Title	Overall Survival
Description	Measured from time of registration to death, or last contact date
Time Frame	assessed every 3 months for 3 years

Outcome Measure Data

Analysis Population Description

Only eligible patients were included in the analyses.

Arm/Group Title	PXD101
Arm/Group Description	Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
Measure Participants	20
Median (95% Confidence Interval) [years]	0.9

3. Secondary Outcome

Title	Progression-free Survival
Description	Measured from date of registration to time of first documentation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.
Time Frame	assessed at week 8, then every 3 months for 3 years

Outcome Measure Data

Analysis Population Description

Only eligible patients were included in the analyses.

Arm/Group Title	PXD101
Arm/Group Description	Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
Measure Participants	20
Median (95% Confidence Interval) [years]	0.2

Adverse Events

Time Frame	After every cycle while on protocol treatment, for a maximum of 2 years
Arm/Group Title	PXD101
Arm/Group Description	Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
All Cause Mortality
	PXD101
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PXD101
	Affected / at Risk (%)	# Events
Total	3/20 (15%)
Blood and lymphatic system disorders
Hemoglobin	1/20 (5%)
Gastrointestinal disorders
Diarrhea	1/20 (5%)
Nausea	1/20 (5%)
Vomiting	1/20 (5%)
General disorders
Fatigue (asthenia, lethargy, malaise)	1/20 (5%)
Investigations
Neutrophils/granulocytes (ANC/AGC)	1/20 (5%)
Platelets	1/20 (5%)
Other (Not Including Serious) Adverse Events
	PXD101
	Affected / at Risk (%)	# Events
Total	18/20 (90%)
Blood and lymphatic system disorders
Hemoglobin	7/20 (35%)
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation	1/20 (5%)
Gastrointestinal disorders
Constipation	2/20 (10%)
Diarrhea	4/20 (20%)
Flatulence	1/20 (5%)
Heartburn/dyspepsia	1/20 (5%)
Nausea	8/20 (40%)
Pain - Abdomen NOS	4/20 (20%)
Vomiting	4/20 (20%)
General disorders
Edema: limb	2/20 (10%)
Fatigue (asthenia, lethargy, malaise)	8/20 (40%)
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)	1/20 (5%)
Injection site reaction/extravasation changes	2/20 (10%)
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS	1/20 (5%)
Infection with unknown ANC - Urinary tract NOS	1/20 (5%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	5/20 (25%)
AST, SGOT (serum glutamic oxaloacetic transaminase)	6/20 (30%)
Alkaline phosphatase	4/20 (20%)
Bilirubin (hyperbilirubinemia)	1/20 (5%)
Cholesterol, serum-high (hypercholesterolemia)	1/20 (5%)
Creatinine	4/20 (20%)
Leukocytes (total WBC)	2/20 (10%)
Lymphopenia	2/20 (10%)
Metabolic/Laboratory-Other (Specify)	2/20 (10%)
Platelets	5/20 (25%)
Prolonged QTc interval	1/20 (5%)
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)	2/20 (10%)
Anorexia	3/20 (15%)
Calcium, serum-high (hypercalcemia)	1/20 (5%)
Calcium, serum-low (hypocalcemia)	1/20 (5%)
Dehydration	1/20 (5%)
Glucose, serum-high (hyperglycemia)	2/20 (10%)
Potassium, serum-high (hyperkalemia)	1/20 (5%)
Sodium, serum-high (hypernatremia)	1/20 (5%)
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	1/20 (5%)
Pain - Back	1/20 (5%)
Pain - Extremity-limb	1/20 (5%)
Pain - Joint	1/20 (5%)
Pain - Muscle	2/20 (10%)
Nervous system disorders
Dizziness	3/20 (15%)
Neurology-Other (Specify)	1/20 (5%)
Neuropathy: sensory	1/20 (5%)
Pain - Head/headache	1/20 (5%)
Psychiatric disorders
Insomnia	1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	1/20 (5%)
Dyspnea (shortness of breath)	1/20 (5%)
Vascular disorders
Flushing	1/20 (5%)
Hot flashes/flushes	2/20 (10%)
Hypertension	1/20 (5%)
Hypotension	2/20 (10%)
Phlebitis (including superficial thrombosis)	2/20 (10%)
Vascular-Other (Specify)	1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.