Pharmacokinetics of Daunorubicin in Young Patients With Cancer

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00673257
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 107
• Locations: 60
• Arm: 1
• Duration (Months): 158.9
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This laboratory study is looking at the pharmacokinetics of daunorubicin in young patients with cancer. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about how patients respond to treatment with certain chemotherapy drugs.

Condition or Disease	Intervention/Treatment	Phase
Unspecified Childhood Solid Tumor, Protocol Specific	Other: pharmacological study; Procedure: dual x-ray absorptimetry	N/A

Detailed Description

OBJECTIVES:

Primary

• Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with malignancy.

Secondary

• Evaluate the relationship between body composition (percent body fat) and the pharmacokinetics of daunorubicin hydrochloride in these patients.

• Correlate the pharmacokinetics of daunorubicin hydrochloride with gender, age, or ethnic background in these patients.

• Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and toxicity.

• Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and renal and hepatic function and complete blood count.

• Explore, in a preliminary fashion, possible genetic polymorphisms that may influence daunorubicin hydrochloride disposition.

OUTLINE: This is a multicenter study.

Patients undergo blood collection prior to, periodically during, and after treatment with daunorubicin hydrochloride for pharmacokinetic analysis.

Patients also undergo body composition testing within 7 days before or after the administration of daunorubicin hydrochloride using dual-energy x-ray absorptiometry.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pharmacokinetics of Daunomycin in Children
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Mar 31, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Pharmacokinetics of Daunorubicin chemotherapy patients Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.

Other: pharmacological study; pharmacological studies; Procedure: dual x-ray absorptimetry; Other Names: DEXA scan dual energy x-ray absorptimetry

Outcome Measures

Primary Outcome Measures

1. Population Estimates for Daunorubicin Hydrochloride Clearance [Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.]

   Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.

2. Population Estimates for Daunorubicin Hydrochloride Volume of Distribution [Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.]

   Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.

Secondary Outcome Measures

1. Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride [Length of study]

   Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (<30% versus >=30%)

2. Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background [Length of Study]

   Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Gender (Male versus Female), Age group (<median age versus >=median age in years), Race (White vs. Black vs. Other)

3. Relationship Between Pharmacokinetics and Toxicity [Length of Study]

   Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities

4. Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count [Length of Study]

   Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values

5. Relationship Between Pharmacokinetics, and Genetic Polymorphisms [Length of Study]

   Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Diagnosis of any malignancy

• Must be receiving a chemotherapy regimen that includes daunorubicin hydrochloride administered as an infusion of any duration for < 24 hours on either a 1- or a 2-day schedule, including bolus and all short infusion schedules

PATIENT CHARACTERISTICS:

• Not pregnant or nursing

• No significant uncontrolled systemic illness

• Large implanted prostheses allowed (should not undergo dual energy x-ray absorptiometry scan)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016-7710
3	Childrens Hospital Los Angeles	Los Angeles	California	United States	90027
4	Children's Hospital of Orange County	Orange	California	United States	92868
5	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	United States	94115
6	Stanford Cancer Center	Stanford	California	United States	94305-5824
7	Alfred I. duPont Hospital for Children	Wilmington	Delaware	United States	19803
8	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
9	Lee Cancer Care of Lee Memorial Health System	Fort Myers	Florida	United States	33901
10	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
11	Sacred Heart Cancer Center at Sacred Heart Hospital	Pensacola	Florida	United States	32504
12	All Children's Hospital	Saint Petersburg	Florida	United States	33701
13	St. Joseph's Cancer Institute at St. Joseph's Hospital	Tampa	Florida	United States	33607
14	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
15	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912-3730
16	Children's Memorial Hospital - Chicago	Chicago	Illinois	United States	60614
17	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
18	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202-5289
19	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
20	Kosair Children's Hospital	Louisville	Kentucky	United States	40232
21	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
22	C.S. Mott Children's Hospital at University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109-0286
23	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
24	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
25	Children's Hospitals and Clinics of Minnesota - Minneapolis	Minneapolis	Minnesota	United States	55404
26	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455
27	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216-4505
28	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
29	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
30	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89109-2306
31	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey	United States	07601
32	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
33	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-5636
34	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York	United States	10032
35	Mission Hospitals - Memorial Campus	Asheville	North Carolina	United States	28801
36	Akron Children's Hospital	Akron	Ohio	United States	44308-1062
37	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039
38	Nationwide Children's Hospital	Columbus	Ohio	United States	43205-2696
39	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
40	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
41	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon	United States	97239-3098
42	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104-9786
43	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
44	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
45	East Tennessee Children's Hospital	Knoxville	Tennessee	United States	37901
46	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105
47	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838
48	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78411
49	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
50	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas	United States	76104
51	Baylor University Medical Center - Houston	Houston	Texas	United States	77030-2399
52	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009
53	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78207
54	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington	United States	98105
55	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington	United States	99220-2555
56	Midwest Children's Cancer Center at Children's Hospital of Wisconsin	Milwaukee	Wisconsin	United States	53226
57	Princess Margaret Hospital for Children	Perth	Western Australia	Australia	6001
58	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
59	Saskatoon Cancer Centre at the University of Saskatchewan	Saskatoon	Saskatchewan	Canada	S7N 4H4
60	Swiss Pediatric Oncology Group Bern	Bern		Switzerland	3010

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Stacey L. Berg, MD, Texas Children's Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT00673257
• Other Study ID Numbers: ABTR06C1; CDR0000490024; COG-ABTR06C1; NCI-2009-00327
• First Posted: May 7, 2008
• Last Update Posted: Apr 14, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Children's Oncology Group: unspecified childhood solid tumor, protocol specific

Study Results

Participant Flow

Arm/Group Title	Pharmacokinetics of Daunorubicin Chemotherapy Patients
Arm/Group Description	Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Period Title: Overall Study
STARTED	107
COMPLETED	102
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Pharmacokinetics of Daunorubicin Chemotherapy Patients
Arm/Group Description	Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Overall Participants	107
Age (Count of Participants)
<=18 years	99 92.5%
Between 18 and 65 years	8 7.5%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.5 (5.1)
Sex: Female, Male (Count of Participants)
Female	35 32.7%
Male	72 67.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	19 17.8%
Not Hispanic or Latino	82 76.6%
Unknown or Not Reported	6 5.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 1.9%
Native Hawaiian or Other Pacific Islander	1 0.9%
Black or African American	13 12.1%
White	82 76.6%
More than one race	2 1.9%
Unknown or Not Reported	7 6.5%

Outcome Measures

1. Primary Outcome

Title	Population Estimates for Daunorubicin Hydrochloride Clearance
Description	Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.
Time Frame	Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.

Outcome Measure Data

Analysis Population Description

There were 107 patients enrolled, 4 participants withdrew consent and there was 1 patient with insufficient specimen. 4 other participants were not analyzed as all sample time points were required for analysis and were not available.

Arm/Group Title	Pharmacokinetics of Daunorubicin Chemotherapy Patients
Arm/Group Description	Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Measure Participants	98
Mean (Standard Deviation) [L/m2/hr]	116 (14)

2. Primary Outcome

Title	Population Estimates for Daunorubicin Hydrochloride Volume of Distribution
Description	Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.
Time Frame	Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.

Outcome Measure Data

Analysis Population Description

There were 107 patients enrolled, 4 participants withdrew consent and there was 1 participant with insufficient specimen. 4 other participants were not analyzed as all samples time points were required for analysis and were not available.

Arm/Group Title	Pharmacokinetics of Daunorubicin Chemotherapy Patients
Arm/Group Description	Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Measure Participants	98
Mean (Standard Deviation) [Liter]	68.1 (24)

3. Secondary Outcome

Title	Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride
Description	Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (<30% versus >=30%)
Time Frame	Length of study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background
Description	Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Gender (Male versus Female), Age group (<median age versus >=median age in years), Race (White vs. Black vs. Other)
Time Frame	Length of Study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Relationship Between Pharmacokinetics and Toxicity
Description	Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities
Time Frame	Length of Study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count
Description	Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values
Time Frame	Length of Study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Relationship Between Pharmacokinetics, and Genetic Polymorphisms
Description	Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype
Time Frame	Length of Study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Pharmacokinetics of Daunorubicin Chemotherapy Patients
Arm/Group Description	Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
All Cause Mortality
	Pharmacokinetics of Daunorubicin Chemotherapy Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pharmacokinetics of Daunorubicin Chemotherapy Patients
	Affected / at Risk (%)	# Events
Total	0/107 (0%)
Other (Not Including Serious) Adverse Events
	Pharmacokinetics of Daunorubicin Chemotherapy Patients
	Affected / at Risk (%)	# Events
Total	50/107 (46.7%)
Blood and lymphatic system disorders
Bone marrow hypocellular	1/107 (0.9%)
Anemia	26/107 (24.3%)
White blood cell decreased	33/107 (30.8%)
Lymphocyte count decreased	21/107 (19.6%)
Neutrophil count decreased	30/107 (28%)
Platelet count decreased	27/107 (25.2%)
General disorders
Pain	1/107 (0.9%)
Infections and infestations
Enterocolitis infectious	1/107 (0.9%)
Febrile neutropenia	9/107 (8.4%)
"Infections and infestations - Other, specify"	9/107 (8.4%)
Investigations
Fibrinogen	2/107 (1.9%)
Metabolism and nutrition disorders
Anorexia	3/107 (2.8%)
Constipation	1/107 (0.9%)
Diarrhea	2/107 (1.9%)
Mucositis oral	1/107 (0.9%)
Nausea	1/107 (0.9%)
Proctitis	1/107 (0.9%)
Vomiting	1/107 (0.9%)
Hypoalbuminemia	1/107 (0.9%)
Alanine aminotransferase increased	8/107 (7.5%)
Hypocalcemia	4/107 (3.7%)
Hypercholestremia	1/107 (0.9%)
GGT increased	1/107 (0.9%)
Hyperglycemia	6/107 (5.6%)
Lipase	2/107 (1.9%)
Hypophosphatemia	1/107 (0.9%)
Hyperkalemia	1/107 (0.9%)
Hypokalemia	2/107 (1.9%)
Hyponatremia	2/107 (1.9%)
Hypertriglyceridemia	1/107 (0.9%)
Tumor lysis syndrome	2/107 (1.9%)
Musculoskeletal and connective tissue disorders
Pain in extremity	2/107 (1.9%)
Nervous system disorders
Syncope	1/107 (0.9%)
Headache	1/107 (0.9%)
Vascular disorders
"Vascular disorders - Other, specify"	1/107 (0.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Must obtain prior Sponsor approval.