Trial Outcomes & Findings for Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment (NCT NCT00453310)

Last Updated: 2015-10-27

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

2 years

Results posted on

2015-10-27

Participant milestones
Measure	Sunitinib Malate The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) sunitinib malate
Overall Study STARTED	10
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	10

Reasons for withdrawal
Measure	Sunitinib Malate The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) sunitinib malate
Overall Study Progression of Disease	10

Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment

Baseline characteristics by cohort
Measure	Sunitinib Malate n=10 Participants The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) sunitinib malate
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants

Timeframe: 2 years

Outcome measures
Measure	Sunitinib Malate n=10 Participants The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) sunitinib malate
Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment Stable Disease	3 participants
Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment Progression of Disease	7 participants

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events
Measure	Sunitinib Malate n=10 participants at risk The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) sunitinib malate
Gastrointestinal disorders Hemorrhage, Abdomen NOS	10.0% 1/10 • Number of events 1

Other adverse events
Measure	Sunitinib Malate n=10 participants at risk The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) sunitinib malate
Blood and lymphatic system disorders ALT, SGPT	20.0% 2/10 • Number of events 2
Blood and lymphatic system disorders Glucose, high (hyperglycemia)	10.0% 1/10 • Number of events 1
General disorders Hemorrhage, Nose	10.0% 1/10 • Number of events 1
Cardiac disorders Hypertension	10.0% 1/10 • Number of events 1
Blood and lymphatic system disorders Leukocytes (total WBC)	40.0% 4/10 • Number of events 4
Blood and lymphatic system disorders Lymphopenia	20.0% 2/10 • Number of events 2
General disorders Mucositis (func/sympt)- Oral cavity	20.0% 2/10 • Number of events 2
Nervous system disorders Neuropathy: motor	10.0% 1/10 • Number of events 1
Nervous system disorders Neuropathy: sensory	10.0% 1/10 • Number of events 1
General disorders Pain - Extremity-limb	10.0% 1/10 • Number of events 1
Skin and subcutaneous tissue disorders Rash/desquamation	10.0% 1/10 • Number of events 1
Renal and urinary disorders Urinary frequency/urgency	10.0% 1/10 • Number of events 1

Memorial Sloan Kettering Cancer Center

Phone: 646-422-4312