Trial Outcomes & Findings for Sunitinib Malate in Refractory Germ Cell Tumors (NCT NCT00912912)

NCT ID: NCT00912912

Last Updated: 2016-04-15

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2016-04-15

Participant Flow

Recruitment Period: May 29, 2009 to July 29, 2010. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.

Study was closed early due to low rate of response and slow accrual.

Participant milestones

Measure	Sunitinib Malate Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Overall Study STARTED	5
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Sunitinib Malate Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Overall Study Withdrawal by Subject	1
Overall Study Disease Progression	3

Baseline Characteristics

Sunitinib Malate in Refractory Germ Cell Tumors

Baseline characteristics by cohort

Measure	Sunitinib Malate n=5 Participants Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Age, Continuous	29 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Measure	Sunitinib Malate n=5 Participants Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate	20 Percentage of Participants

Adverse Events

Sunitinib Malate

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sunitinib Malate n=5 participants at risk Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Musculoskeletal and connective tissue disorders PAIN (MID-BACK)	20.0% 1/5 • Number of events 1 • 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.
General disorders PAIN (LEFT-CHEST)	20.0% 1/5 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders PAIN (THORACIC BACK)	20.0% 1/5 • Number of events 1 • 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.
Nervous system disorders HEADACHE	20.0% 1/5 • Number of events 1 • 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.
Vascular disorders HEMORRHAGE	20.0% 1/5 • Number of events 1 • 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.
General disorders DEATH	20.0% 1/5 • Number of events 1 • 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.
General disorders WEAKNESS	20.0% 1/5 • Number of events 1 • 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.

Other adverse events

Measure	Sunitinib Malate n=5 participants at risk Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Gastrointestinal disorders CONSTIPATION	40.0% 2/5 • Number of events 7 • 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.
Psychiatric disorders MOOD ALTERATION (DEPRESSION)	20.0% 1/5 • Number of events 1 • 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.
Gastrointestinal disorders NAUSEA	60.0% 3/5 • Number of events 5 • 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.
Gastrointestinal disorders VOMITING	40.0% 2/5 • Number of events 7 • 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.
General disorders FATIGUE	80.0% 4/5 • Number of events 17 • 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.
Nervous system disorders NEUROPATHY: SENSORY	80.0% 4/5 • Number of events 5 • 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.
General disorders INSOMNIA	20.0% 1/5 • Number of events 1 • 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.
General disorders PAIN (OTHER)	40.0% 2/5 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders PAIN (EXTREMITY - LIMB)	40.0% 2/5 • Number of events 2 • 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.
Gastrointestinal disorders PAIN (ABDOMEN)	60.0% 3/5 • Number of events 4 • 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.
Skin and subcutaneous tissue disorders ALOPECIA	40.0% 2/5 • Number of events 2 • 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.
Blood and lymphatic system disorders HEMOGLOBIN	80.0% 4/5 • Number of events 9 • 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.
Respiratory, thoracic and mediastinal disorders COUGH	20.0% 1/5 • Number of events 1 • 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.
Gastrointestinal disorders ANOREXIA	40.0% 2/5 • Number of events 5 • 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.
Skin and subcutaneous tissue disorders RASH/DESQUAMATION	60.0% 3/5 • Number of events 4 • 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.
Respiratory, thoracic and mediastinal disorders DYSPNEA	40.0% 2/5 • Number of events 4 • 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.
Gastrointestinal disorders DIARRHEA	40.0% 2/5 • Number of events 3 • 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.
Skin and subcutaneous tissue disorders HYPOPIGMENTATION	40.0% 2/5 • Number of events 4 • 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.
General disorders WEIGHT LOSS	20.0% 1/5 • Number of events 1 • 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.
General disorders PAIN (CHEST/THORAX)	40.0% 2/5 • Number of events 2 • 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.
Cardiac disorders SUPRAVENTRICULAR AND NODAL ARRHYTHMIA	40.0% 2/5 • Number of events 2 • 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.
Blood and lymphatic system disorders PLATELETS	60.0% 3/5 • Number of events 4 • 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.
Blood and lymphatic system disorders NEUTROPHILS/GRANULOCYTES	60.0% 3/5 • Number of events 3 • 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.
Skin and subcutaneous tissue disorders BRUISING	20.0% 1/5 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders PAIN (BACK)	40.0% 2/5 • Number of events 2 • 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.
Metabolism and nutrition disorders HYPOMAGNESEMIA	40.0% 2/5 • Number of events 2 • 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.
Metabolism and nutrition disorders PROTEINURIA	40.0% 2/5 • Number of events 2 • 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.
Nervous system disorders HEADACHE	20.0% 1/5 • Number of events 1 • 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.
Gastrointestinal disorders ULCER - GI	20.0% 1/5 • Number of events 1 • 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.
Metabolism and nutrition disorders CREATININE	20.0% 1/5 • Number of events 1 • 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.
Metabolism and nutrition disorders HYPERBILIRUBINEMIA	20.0% 1/5 • Number of events 5 • 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.
Blood and lymphatic system disorders LYMPHOPENIA	20.0% 1/5 • Number of events 2 • 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.
Endocrine disorders HYPOTHYROIDISM	20.0% 1/5 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL/SOFT TISSUE - OTHER	20.0% 1/5 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders DRY SKIN	20.0% 1/5 • Number of events 2 • 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.
Gastrointestinal disorders GASTROINTESTINAL - OTHER	20.0% 1/5 • Number of events 1 • 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.
Metabolism and nutrition disorders HYPERGLYCEMIA	20.0% 1/5 • Number of events 1 • 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.
Endocrine disorders ENDOCRINE - OTHER	20.0% 1/5 • Number of events 1 • 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.
Nervous system disorders NEUROLOGY - OTHER	20.0% 1/5 • Number of events 2 • 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.
Gastrointestinal disorders MUCOSITIS/STOMATITIS	80.0% 4/5 • Number of events 13 • 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.
Blood and lymphatic system disorders LEUKOCYTES	80.0% 4/5 • Number of events 6 • 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.

Additional Information

Lance Pagliaro, MD/Genitourinary Medical Oncology

The University of Texas (UT) MD Anderson Cancer Center

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place