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Sunitinib Malate in Refractory Germ Cell Tumors

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ClinicalTrials.gov Identifier: NCT00912912
Recruitment Status : Terminated (Slow Accrual)
First Posted : June 3, 2009
Results First Posted : January 27, 2016
Last Update Posted : April 15, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Genitourinary Disease
Intervention Drug: Sunitinib Malate
Enrollment 5
Recruitment Details Recruitment Period: May 29, 2009 to July 29, 2010. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details Study was closed early due to low rate of response and slow accrual.
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Period Title: Overall Study
Started 5
Completed 1
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Disease Progression             3
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
29
(17 to 36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
0
   0.0%
Male
5
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  20.0%
White
3
  60.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title 12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate
Hide Description Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description:
Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Percentage of Participants
20
Time Frame Adverse event collection through each cycle, defined as a planned 6-week treatment interval (cycle) with participants to complete at least 2 cycles of therapy unless evidence of rapid disease progression.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib Malate
Hide Arm/Group Description Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
All-Cause Mortality
Sunitinib Malate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib Malate
Affected / at Risk (%) # Events
Total   3/5 (60.00%)    
General disorders   
PAIN (LEFT-CHEST)  1  1/5 (20.00%)  1
DEATH  1  1/5 (20.00%)  1
WEAKNESS  1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
PAIN (MID-BACK)  1  1/5 (20.00%)  1
PAIN (THORACIC BACK)  1  1/5 (20.00%)  1
Nervous system disorders   
HEADACHE  1  1/5 (20.00%)  1
Vascular disorders   
HEMORRHAGE  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib Malate
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
HEMOGLOBIN  1  4/5 (80.00%)  9
PLATELETS  1  3/5 (60.00%)  4
NEUTROPHILS/GRANULOCYTES  1  3/5 (60.00%)  3
LYMPHOPENIA  1  1/5 (20.00%)  2
LEUKOCYTES  1  4/5 (80.00%)  6
Cardiac disorders   
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA  1  2/5 (40.00%)  2
Endocrine disorders   
HYPOTHYROIDISM  1  1/5 (20.00%)  1
ENDOCRINE - OTHER  1  1/5 (20.00%)  1
Gastrointestinal disorders   
CONSTIPATION  1  2/5 (40.00%)  7
NAUSEA  1  3/5 (60.00%)  5
VOMITING  1  2/5 (40.00%)  7
PAIN (ABDOMEN)  1  3/5 (60.00%)  4
ANOREXIA  1  2/5 (40.00%)  5
DIARRHEA  1  2/5 (40.00%)  3
ULCER - GI  1  1/5 (20.00%)  1
GASTROINTESTINAL - OTHER  1  1/5 (20.00%)  1
MUCOSITIS/STOMATITIS  1  4/5 (80.00%)  13
General disorders   
FATIGUE  1  4/5 (80.00%)  17
INSOMNIA  1  1/5 (20.00%)  1
PAIN (OTHER)  1  2/5 (40.00%)  3
WEIGHT LOSS  1  1/5 (20.00%)  1
PAIN (CHEST/THORAX)  1  2/5 (40.00%)  2
Metabolism and nutrition disorders   
HYPOMAGNESEMIA  1  2/5 (40.00%)  2
PROTEINURIA  1  2/5 (40.00%)  2
CREATININE  1  1/5 (20.00%)  1
HYPERBILIRUBINEMIA  1  1/5 (20.00%)  5
HYPERGLYCEMIA  1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
PAIN (EXTREMITY - LIMB)  1  2/5 (40.00%)  2
PAIN (BACK)  1  2/5 (40.00%)  2
MUSCULOSKELETAL/SOFT TISSUE - OTHER  1  1/5 (20.00%)  1
Nervous system disorders   
NEUROPATHY: SENSORY  1  4/5 (80.00%)  5
HEADACHE  1  1/5 (20.00%)  1
NEUROLOGY - OTHER  1  1/5 (20.00%)  2
Psychiatric disorders   
MOOD ALTERATION (DEPRESSION)  1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
COUGH  1  1/5 (20.00%)  1
DYSPNEA  1  2/5 (40.00%)  4
Skin and subcutaneous tissue disorders   
ALOPECIA  1  2/5 (40.00%)  2
RASH/DESQUAMATION  1  3/5 (60.00%)  4
HYPOPIGMENTATION  1  2/5 (40.00%)  4
BRUISING  1  1/5 (20.00%)  1
DRY SKIN  1  1/5 (20.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Lance Pagliaro, MD/Genitourinary Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00912912     History of Changes
Other Study ID Numbers: 2006-0685
NCI-2012-01645 ( Registry Identifier: NCI CTRP )
First Submitted: June 1, 2009
First Posted: June 3, 2009
Results First Submitted: December 21, 2015
Results First Posted: January 27, 2016
Last Update Posted: April 15, 2016